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fda.gov
Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices | FDA

By
Nguyen Rin
1
Use for Free
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CSV JSON HTML Changes
sorting_1aa-hreftdtd 1td 2td 3Date of Final DecisionColumn 2Column 3Submission NumberColumn 5numSubmission NumberColumn 8Column 9Column 10Companyorigin_patternorigin_urlcreatedAtupdatedAtpingedAt
DEN130013https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN130013Vitek MSBiomerieux, Inc.MicrobiologyPEXhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN130013Show 10 25 50 100 All entries Export ExcelDEN13001310 25 50 100 AllDEN130013DEN160026DEN130013https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
DEN140025https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN140025BrainScope Ahead 100BrainScope Company, Inc.NeurologyPIWSubmission Numberhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN140025Submission NumberDEN140025Submission NumberDEN140025DEN140025Date of Final Decision, Submission Number, Device, Company, Panel (Lead), Primary...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
DEN160026https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN16002623andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thr...23andMe, Inc.HematologyPTAhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN160026DEN160026DEN160026DEN160026https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
DEN160044https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN160044Acumen Hypotension Prediction Index (HPI) Feature SoftwareEdwards Lifesciences LLCCardiovascularQAQhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN160044DEN160044DEN160044DEN160044https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
DEN170022https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN170022QuantXQuantitative Insights, IncRadiologyPOKhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN170022DEN170022DEN170022DEN170022https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
DEN170043https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170043DreaMed Advisor ProDreaMed Diabetes, Ltd.Clinical ChemistryQCChttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170043DEN170043DEN170043DEN170043https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
DEN170073https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170073ContaCTViz.Al, Inc.RadiologyQAShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170073DEN170073DEN170073DEN170073https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
DEN170091https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm?ID=DEN170091EyeBOXOculogica, Inc.NeurologyQEAhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm?ID=DEN170091DEN170091DEN170091DEN170091https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
DEN180001https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN180001IDx-DRIDx, LLCOphthalmicPIBhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN180001DEN180001DEN180001DEN180001https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
DEN180005https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN180005OsteoDetectImagen Technologies, Inc.RadiologyQBShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN180005DEN180005DEN180005DEN180005https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
DEN190040https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm?ID=DEN190040Caption GuidanceBay Labs, Inc.RadiologyQJUhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm?ID=DEN190040DEN190040DEN190040DEN190040https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
DEN200019https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200019Oxehealth Vital SignsOxehealth LimitedCardiovascularQMEhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200019DEN200019DEN200019DEN200019https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
DEN200022https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200022Analytic for Hemodynamic Instability (AHI)Fifth Eye Inc.CardiovascularQNVhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200022DEN200022DEN200022DEN200022https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
DEN200030https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200030Feops HEARTguideFeops NVCardiovascularQQIhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200030DEN200030DEN200030DEN200030https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
DEN200038https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200038Gili Pro Biosensor (Also Known as Gili Biosensor System)Continuse Biometrics Ltd.CardiovascularQOKhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200038DEN200038DEN200038DEN200038https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
DEN200055https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200055GI GeniusCosmo Artificial Intelligence - AI, Ltd.Gastroenterology-UrologyQNPhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200055DEN200055DEN200055DEN200055https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
DEN200069https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200069Cognoa Asd Diagnosis AidCognoa, Inc.NeurologyQPFhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200069DEN200069DEN200069DEN200069https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
DEN200080https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200080Paige ProstatePaige.AIPathologyQPNhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200080DEN200080DEN200080DEN200080https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K003301https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K003301DiffMaster Octavia Automatic Hematology AnalyzerCellaVision ABHematologyJOYhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K003301K003301K003301K003301https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K033840https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K033840CellaVision DM96 Automatic Hematology AnalyzerCella Vision ABHematologyJOYhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K033840K033840K033840K033840https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K080595https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K080595CellaVision DM96 with the body fluid applicationCella Vision ABHematologyJOYhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K080595K080595K080595K080595https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K080762https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K080762IB Neuro, Version 1.0Imaging Biometrics, LLCRadiologyLNHhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K080762K080762K080762K080762https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K080896https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K080896Pathwork Tissue of Origin TestPathwork Diagnostics Inc.PathologyOIWhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K080896K080896K080896K080896https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K081140https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K081140VisensiaOBS MedicalCardiovascularMHXhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K081140K081140K081140K081140https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K082483https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K082483QuantraHologic, Inc.RadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K082483K082483K082483K082483https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K092116https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K092116EasyCellMedica CorporationHematologyJOYhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K092116K092116K092116K092116https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K102778https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K102778CellaVision® DM1200 with the body fluid applicationCellaVision ABHematologyJOYhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K102778K102778K102778K102778https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K111776https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K111776DeltaView Model 2.1Riverain Medical Group,LlcRadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K111776K111776K111776K111776https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K120161https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K120161AlphaPoint Imaging SoftwareRadLogics, Inc.RadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K120161K120161K120161K120161https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K120489https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K120489Tissue of Origin Test Kit FFPEPathwork Diagnostics, Inc.PathologyOIWhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K120489K120489K120489K120489https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K120771https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K120771UniCel DxH 800 Coulter Cellular Analysis SystemBeckman Coulter, Inc.HematologyGKZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K120771K120771K120771K120771https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K123526https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K123526ClearRead +ConfirmRiverain TechnologiesRadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K123526K123526K123526K123526https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K130831https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130831MALDI Biotyper CA (MBT-CA) SystemBruker Daltonics, Inc.MicrobiologyPEXhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130831K130831K130831K130831https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K133259https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133259Ysio MaxSiemens Medical Solutions USA, Inc.RadiologyKPRhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133259K133259K133259K133259https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K133649https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K133649Hepatic VCARGE Medical Systems SCSRadiologyJAKhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K133649K133649K133649K133649https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K141069https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K141069Lung Density AnalysisImbio LLCRadiologyJAKhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K141069K141069K141069K141069https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K141480https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K141480CVI42Circle Cardiovascular Imaging IncRadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K141480K141480K141480K141480https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K141922https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141922IRIS Intelligent Retinal Imaging SystemIRIS Intelligent Retinal Imaging Systems, LLCOphthalmicNFJhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141922K141922K141922K141922https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K142037https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K142037QuantraHologic, Inc.RadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K142037K142037K142037K142037https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K142512https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K142512Personalized Physiology Analytics Engine SoftwareVGBio, Inc. (DBA PhysIQ)CardiovascularPLBhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K142512K142512K142512K142512https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K142918https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142918EndoTool SubQMonarch Medical TechnologiesGeneral HospitalNDChttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142918K142918K142918K142918https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K150102https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150102SnoreSoundsAppian Medical Inc.AnesthesiologyMNRhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150102K150102K150102K150102https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K150817https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150817Dario Blood Glucose Monitoring SystemLabStyle Innovations Ltd.Clinical ChemistryNBWhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150817K150817K150817K150817https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K152733https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K152733FFRctHeartFlow, Inc.CardiovascularPJAhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K152733K152733K152733K152733https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K153351https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K153351Quantib Brain 1Quantib BVRadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K153351K153351K153351K153351https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K153427https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K153427Volpara Imaging SoftwareMatakina Technology Ltd.RadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K153427K153427K153427K153427https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K160016https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K160016Steth IOStratoscientific, Inc.CardiovascularDQDhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K160016K160016K160016K160016https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K160088https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160088Cydar EVCydar Ltd.RadiologyOWBhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160088K160088K160088K160088https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K160338https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160338Triton SystemGauss Surgical Inc.General And Plastic SurgeryPBZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160338K160338K160338K160338https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K160401https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160401Tyto StethoscopeTyto Care Ltd.CardiovascularDQDhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160401K160401K160401K160401https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K161068https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161068Ahead 300Brainscope Company Inc.NeurologyPIWhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161068K161068K161068K161068https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K161148https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161148IcobrainIcometrixRadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161148K161148K161148K161148https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K161201https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161201ClearRead CTRiverain Technologies, LLCRadiologyOEBhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161201K161201K161201K161201https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K161322https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161322CT CoPilotZepmed, LLCRadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161322K161322K161322K161322https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K161382https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161382LVivo Software ApplicationDiACardio, Ltd.RadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161382K161382K161382K161382https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K161625https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161625PixelShineAlgoMedicaRadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161625K161625K161625K161625https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K161772https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161772FFRct v2.0HeartFlow, Inc.CardiovascularPJAhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161772K161772K161772K161772https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K161834https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161834One Drop Blood Glucose Monitoring SystemAgaMatrix Inc.Clinical ChemistryNBWhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161834K161834K161834K161834https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K161959https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161959ClearView CCADClearView Diagnostics Inc.RadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K161959K161959K161959K161959https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K162627https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K162627EnsoSleepEnsoData, Inc.NeurologyOLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K162627K162627K162627K162627https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K162830https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K162830SIS SoftwareSurgical Information Sciences, Inc.RadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K162830K162830K162830K162830https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K163013https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163013Quantib Brain 1.2Quantib BVRadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163013K163013K163013K163013https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K163138https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163138Clarius Ultrasound SystemClarius Mobile Health Corp.RadiologyIYNhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163138K163138K163138K163138https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K163253https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163253Arterys Cardio DLArterys Inc.RadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163253K163253K163253K163253https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K163339https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163339SpectralMD DeepView Wound Imaging System 2.0SpectralMD, Inc.CardiovascularDPThttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163339K163339K163339K163339https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K163622https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163622Lung VisionBody Vision Medical Ltd.RadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163622K163622K163622K163622https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K163623https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163623QuantraHologic, Inc.RadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163623K163623K163623K163623https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K163665https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163665MATRx PlusZephyr Sleep TechnologiesAnesthesiologyMNRhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163665K163665K163665K163665https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K163694https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163694Rooti Rx ECG Event Recorder, Rooti Link APP SoftwareRooti Labs Ltd.CardiovascularDRGhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K163694K163694K163694K163694https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K170069https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170069AmCAD-UVAmCad BioMed CorporationRadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170069K170069K170069K170069https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K170172https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170172UNiD Spine AnalyzerMedicrea InternationalRadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170172K170172K170172K170172https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K170250https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170250SmartTargetSmarTarget, Ltd.RadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170250K170250K170250K170250https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K170540https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170540DM-DensityDensitas, Inc.RadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170540K170540K170540K170540https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K170568https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170568CardioLogs ECG Analysis PlatformCardiologs TechnologiesCardiovascularDPShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170568K170568K170568K170568https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K170747https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170747Syngo Application SoftwareSiemens Medical Solutions, USA, Inc.RadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170747K170747K170747K170747https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K170981https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170981NeuroQuantCorTechs Labs, IncRadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170981K170981K170981K170981https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K171056https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K171056WAVE Clinical PlatformExcel Medical Electronics, LLCCardiovascularMWIhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K171056K171056K171056K171056https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K171122https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171122CEREC Ortho SoftwareDentsply SironaDentalPNNhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171122K171122K171122K171122https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K171315https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K171315Advanced RBC ApplicationCella Vision ABHematologyJOYhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K171315K171315K171315K171315https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K171328https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171328CNeuro CMRICombinostics OyRadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171328K171328K171328K171328https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K171936https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K171936Peerbridge Cor(TM) SystemPeerbridge Health Inc.CardiovascularDSHhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K171936K171936K171936K171936https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K172122https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172122SOZOImpediMed LimitedGastroenterology-UrologyOBHhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172122K172122K172122K172122https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K172356https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172356BladderScan Prime PLUS SystemVerathon IncorporatedRadiologyIYOhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172356K172356K172356K172356https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K172385https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172385Clarius Ultrasound SystemClarius Mobile Health Corp.RadiologyIYNhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172385K172385K172385K172385https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K172507https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172507SOZOImpediMed LimitedCardiovascularDSBhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172507K172507K172507K172507https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K172803https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172803Infinitt PACS 7.0Infinitt Healthcare Co.,Ltd.RadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172803K172803K172803K172803https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K172959https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172959PeraServer and PeraTrendPeraHealth, Inc.CardiovascularMWIhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172959K172959K172959K172959https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K172983https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172356HealthCCSZebra Medical Vision Ltd.RadiologyJAKhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K172356K172983K172983K172983https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K173327https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173327DIP/U.S. Urine Analysis Test SystemHealthy.io LtdClinical ChemistryJILhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173327K173327K173327K173327https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K173420https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173420Radiomics App V1.0Microsoft Corp.RadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173420K173420K173420K173420https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K173444https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173444Quantitative Total Extensible Imaging (QTxi)AIQ Solutions, Inc.RadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173444K173444K173444K173444https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K173542https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173542Arterys Oncology DlArterys Inc.RadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173542K173542K173542K173542https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K173574https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173574DenSeeMammoSTATLIFERadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173574K173574K173574K173574https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K173588https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173588Illumeo SystemPhilips Medical Systems Technologies, LtdRadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173588K173588K173588K173588https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K173605https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173605IQMRMedic Vision - Imaging Solutions LtdRadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173605K173605K173605K173605https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K173749https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173749AMRA ProfilerAMRA Medical ABRadiologyLNHhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173749K173749K173749K173749https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K173780https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173780EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc.RadiologyLLZhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173780K173780K173780K173780https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K173810https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173810Ventripoint Medical System Plus (VMS+)Ventripoint Diagnostics, Ltd.RadiologyIYNhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173810K173810K173810K173810https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K173821https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173821LungQ SoftwareThirona CorporationRadiologyJAKhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173821K173821K173821K173821https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
K173872https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173872FibriCheckQompium NVCardiovascularDXHhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173872K173872K173872K173872https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intel...2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC2022-11-02 05:20:58 UTC
Data source unique ID
n112718_6276edcfeae1db270f6abc199d9251edeses
Privacy
Public
Last ran status
COMPLETED
Last ran
2022-11-02 05:20:58 UTC
Crawl Frequency
Not scheduled
Urls to Monitor
Use default URL in recipe

Sample code snippets to quickly import data set into your application

For more information on how to automatically trigger an import please reference our WebHook API guide


Integrating with Java

import java.io.BufferedReader;
import java.io.InputStreamReader;
import java.net.URL;
import java.net.URLConnection;
import java.util.Arrays;

public class HelloWorld {
  public static void main(String[] args) {

    try {
      URL urlCSV = new URL(
        "https://cache.getdata.io/n112718_6276edcfeae1db270f6abc199d9251edeses/latest_all.csv"
      );

      URLConnection urlConn = urlCSV.openConnection();
      InputStreamReader inputCSV = new InputStreamReader(
        ((URLConnection) urlConn).getInputStream()
      );
      BufferedReader br = new BufferedReader(inputCSV);

      String line;
      String[] fields;
      while ((line = br.readLine()) != null) {
        // Each row
        fields = line.split(",");
        System.out.println(Arrays.toString(fields));

      }
      // clean up buffered reader
      br.close();


    } catch (Exception e) {
      System.out.println(e.getMessage());
    }
  }   
}


Integrating with NodeJs

const csv     = require('csv-parser');
const https   = require('https');
const fs      = require('fs');

const file = fs.createWriteStream("temp_download.csv");
const request = https.get(
  "https://cache.getdata.io/n112718_6276edcfeae1db270f6abc199d9251edeses/latest_all.csv", 
  function(response) {
    response.pipe(file);
  }
);

file.on('finish', function() {
  file.close();
  fs.createReadStream('temp_download.csv').pipe(csv()).on('data', (row) => {
    // Each row
    console.log(row);

  }).on('end', () => {
    console.log('CSV file successfully processed');

  });
});



Integrating with PHP

$data = file_get_contents("https://cache.getdata.io/n112718_6276edcfeae1db270f6abc199d9251edeses/latest_all.csv");
$rows = explode("\n",$data);
$s = array();
foreach($rows as $row) {

  # Each row
  var_dump( $row);
  
}


Integrating with Python

import csv
import urllib2

url = 'https://cache.getdata.io/n112718_6276edcfeae1db270f6abc199d9251edeses/latest_all.csv'
response = urllib2.urlopen(url)
cr = csv.reader(response)

for row in cr:
  # Each row
  print row


Integrating with Ruby

require 'open-uri'
require 'tempfile'
require 'csv'

temp_file = Tempfile.new( "getdata", :encoding => 'ascii-8bit')
temp_file << open("https://cache.getdata.io/n112718_6276edcfeae1db270f6abc199d9251edeses/latest_all.csv").read
temp_file.rewind

CSV.foreach( open(uri), :headers => :first_row ).each do |row|      
  # Each row
  puts row
end

Nguyen Rin owner

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