80 devices · 68 companies · 2019
AI-enabled medical devices FDA authorized in 2019
80 devices authorized in 2019, 2019, from 68 companies across 36 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (76 of 80 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes authorized in 2019
- LLZ · System, Image Processing, Radiological21
- JAK · System, X-Ray, Tomography, Computed8
- QAS · Radiological Computer-Assisted Triage And Notification Software5
- QFM · Radiological Computer-Assisted Prioritization Software For Lesions4
- LNH · System, Nuclear Magnetic Resonance Imaging3
- MUJ · System, Planning, Radiation Therapy Treatment3
- DQK · Computer, Diagnostic, Programmable3
- QIH · Automated Radiological Image Processing Software2
- QDQ · Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer2
- GXY · Electrode, Cutaneous2
- DXH · Transmitters And Receivers, Electrocardiograph, Telephone2
- QEK · Angiographic Coronary Vascular Physiologic Simulation Software1
- HAW · Neurological Stereotaxic Instrument1
- QJB · Adjunct Monitor, Protein Calorie Malnutrition1
- MRZ · Accessories, Pump, Infusion1
- MUD · Oximeter, Tissue Saturation1
- GKZ · Counter, Differential Cell1
- JAA · System, X-Ray, Fluoroscopic, Image-Intensified1
- PIW · Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid1
- MWI · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1
- IYN · System, Imaging, Pulsed Doppler, Ultrasonic1
- PJA · Coronary Vascular Physiologic Simulation Software1
- PLB · Multivariate Vital Signs Index1
- QEA · Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid1
- JFY · Enzymatic Method, Creatinine1
- PBH · Embryo Image Assessment System, Assisted Reproduction1
- QCC · Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals1
- DPS · Electrocardiograph1
- POK · Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer1
- QER · Camera, Ophthalmic, Slit-Scanning1
- QAQ · Adjunctive Predictive Cardiovascular Indicator1
- PPU · Microbial Colony Image Assessment System1
- OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay1
- DQD · Stethoscope, Electronic1
- DQA · Oximeter1
- NDC · Calculator, Drug Dose1
Panels
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | Product code | FDA |
|---|---|---|---|---|---|
| BriefCaseK192383 · 510(k) | Aidoc Medical, Ltd. | Radiology | QAS | database entry | |
| QLAB Advanced Quantification SoftwareK191647 · 510(k) | Philips Healthcare | Radiology | QIH | database entry | |
| syngo.CT CaScoringK192763 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | JAK | database entry | |
| QyScore SoftwareK192531 · 510(k) | Qynapse | Radiology | LLZ | database entry | |
| Deep Learning Image ReconstructionK193170 · 510(k) | GE Healthcare Japan Corporation | Radiology | JAK | database entry | |
| IcobrainK192130 · 510(k) | Icometrix NV | Radiology | LLZ | database entry | |
| NemoScanK192571 · 510(k) | Software Nemotec S.L. | Radiology | LLZ | database entry | |
| TransparaK192287 · 510(k) | Screenpoint Medical B.V. | Radiology | QDQ | database entry | |
| FFRangioK192442 · 510(k) | CathWorks Ltd | Cardiovascular | QEK | database entry | |
| PhantomMSK TraumaK192279 · 510(k) | OrthoGrid Systems Inc. | Radiology | LLZ | database entry | |
| 7D Surgical System Cranial Biopsy and VentriculaK192945 · 510(k) | 7D Surgical Inc. | Neurology | HAW | database entry | |
| HealthCXRK192320 · 510(k) | Zebra Medical Vision, Ltd. | Radiology | QFM | database entry | |
| SOZOK190529 · 510(k) | ImpediMed Limited | Cardiovascular | QJB | database entry | |
| RSI-MRI+K191278 · 510(k) | MultiModal Imaging Services Corporation (dba HealthLytix) | Radiology | LLZ | database entry | |
| EchoGo CoreK191171 · 510(k) | Ultromics Ltd | Radiology | QIH | database entry | |
| MEDIP PROK191026 · 510(k) | MEDICALIP Co., Ltd | Radiology | LLZ | database entry | |
| Cleerly LabsK190868 · 510(k) | Cleerly Inc | Radiology | LLZ | database entry | |
| KOALAK192109 · 510(k) | IB Lab GmbH | Radiology | LLZ | database entry | |
| WellDoc BlueStarK190013 · 510(k) | WellDoc, Inc. | General Hospital | MRZ | database entry | |
| MIMOSA ImagerK190334 · 510(k) | MIMOSA Diagnostics Inc | Cardiovascular | MUD | database entry | |
| Sight OLOK190898 · 510(k) | Sight Diagnostics Ltd. | Hematology | GKZ | database entry | |
| RTHawk, HeartVista Cardiac PackageK183274 · 510(k) | HeartVista, Inc. | Radiology | LNH | database entry | |
| Merge PACSK192455 · 510(k) | Merge Healthcare Incorporated | Radiology | LLZ | database entry | |
| Ventripoint Medical System PlusK191493 · 510(k) | Ventripoint Diagnostics, Ltd. | Radiology | LLZ | database entry | |
| ProFound AI Software V2.1K191994 · 510(k) | iCAD Inc. | Radiology | QDQ | database entry | |
| CS-series-FP Radiographic / Fluoroscopic SystemsK191713 · 510(k) | Omega Medical Imaging, LLC | Radiology | JAA | database entry | |
| Syngo.Via RT Image SuiteK192065 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | MUJ | database entry | |
| SubtleMRK191688 · 510(k) | Subtle Medical, Inc. | Radiology | LLZ | database entry | |
| SIS Software Version 3.6.0K192304 · 510(k) | Surgical Information Sciences, Inc. | Radiology | LLZ | database entry | |
| BrainScope TBIK190815 · 510(k) | BrainScope Company, Inc. | Neurology | PIW | database entry | |
| PeraMobile and PeraWatchK183370 · 510(k) | PeraHealth, Inc. | Cardiovascular | MWI | database entry | |
| AI-Rad CompanionK183268 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | JAK | database entry | |
| Myo PlusK191179 · 510(k) | Otto Bock Healthcare Products GmbH | Neurology | GXY | database entry | |
| D2PK183489 · 510(k) | 3D Systems, Inc. | Radiology | LLZ | database entry | |
| Clarius Ultrasound ScannerK192107 · 510(k) | Clarius Mobile Health Corp. | Radiology | IYN | database entry | |
| Zio XT ECG Monitoring System, Zio AT ECG MonitorK190593 · 510(k) | iRhythm Technologies, Inc. | Cardiovascular | DQK | database entry | |
| HeartFlow FFRct AnalysisK190925 · 510(k) | HeartFlow, Inc. | Cardiovascular | PJA | database entry | |
| Biovitals Analytics EngineK183282 · 510(k) | Biofourmis Singapore Pte. Ltd | Cardiovascular | PLB | database entry | |
| Critical Care SuiteK183182 · 510(k) | GE Medical Systems, LLC. | Radiology | QFM | database entry | |
| aBSIK191262 · 510(k) | EXINI Diagnostics AB | Radiology | LLZ | database entry | |
| EyeBOXK191183 · 510(k) | Oculogica, Inc. | Neurology | QEA | database entry | |
| ACR LAB Urine Analysis Test SystemK182384 · 510(k) | Healthy.io Ltd | Clinical Chemistry | JFY | database entry | |
| AI-Rad CompanionK183271 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | JAK | database entry | |
| KIDScore D3K182798 · 510(k) | Vitrolife A/S | Obstetrics and Gynecology | PBH | database entry | |
| DreaMed Advisor ProK191370 · 510(k) | DreaMed Diabetes Ltd | Clinical Chemistry | QCC | database entry | |
| iNtuition-Structural Heart ModuleK191585 · 510(k) | TeraRecon Inc. | Radiology | LLZ | database entry | |
| physIQ Heart Rhythm and Respiratory ModuleK183322 · 510(k) | physIQ, Inc | Cardiovascular | DPS | database entry | |
| DeepCTK182875 · 510(k) | Deep01 Limited | Radiology | QAS | database entry | |
| RayCare 2.3K191384 · 510(k) | RaySearch Laboratories AB (publ) | Radiology | MUJ | database entry | |
| Aquilion PrecisionK182901 · 510(k) | Canon Medical Systems Corporation | Radiology | JAK | database entry | |
| Koios DS for BreastK190442 · 510(k) | Koios Medical, Inc. | Radiology | POK | database entry | |
| LiverMultiScanK190017 · 510(k) | Perspectum Diagnostics Ltd | Radiology | LNH | database entry | |
| CLARUSK191194 · 510(k) | Carl Zeiss Meditec, Inc | Ophthalmic | QER | database entry | |
| RayStationK190387 · 510(k) | RaySearch Laboratories AB (publ) | Radiology | MUJ | database entry | |
| ClariCT.AIK183460 · 510(k) | ClariPI Inc. | Radiology | LLZ | database entry | |
| HealthICHK190424 · 510(k) | Zebra Medical Vision Ltd. | Radiology | QAS | database entry | |
| Aquilion ONEK183046 · 510(k) | Canon Medical Systems Corporation | Radiology | JAK | database entry | |
| BriefCaseK190896 · 510(k) | Aidoc Medical, Ltd. | Radiology | QAS | database entry | |
| COMPLETE CONTROL System Gen2K191083 · 510(k) | Coapt, LLC | Neurology | GXY | database entry | |
| Acumen Hypotension Prediction Index EV1000 CliK183646 · 510(k) | Edwards Lifeciences, LLC | Cardiovascular | QAQ | database entry | |
| APAS Independence with Urine Analysis ModuleK183648 · 510(k) | Clever Culture Systems AG | Microbiology | PPU | database entry | |
| SurgicalARK190764 · 510(k) | MEDIVIS, Inc. | Radiology | LLZ | database entry | |
| HealthPNXK190362 · 510(k) | Zebra Medical Vision Ltd. | Radiology | QFM | database entry | |
| FluChip-8G Influenza A+B AssayK182513 · 510(k) | InDevR, Inc. | Microbiology | OZE | database entry | |
| Lung Vision SystemK183593 · 510(k) | Body Vision Medical Ltd. | Radiology | LLZ | database entry | |
| eMurmur IDK181988 · 510(k) | CSD Labs GmbH | Cardiovascular | DQD | database entry | |
| BriefCaseK190072 · 510(k) | Aidoc Medical, Ltd. | Radiology | QAS | database entry | |
| Deep Learning Image ReconstructionK183202 · 510(k) | GE Medical Systems, LLC. | Radiology | JAK | database entry | |
| Bone VCARK183204 · 510(k) | GE Medical Systems SCS | Radiology | JAK | database entry | |
| Loop SystemK181352 · 510(k) | Spry Health, Inc. | Cardiovascular | DQA | database entry | |
| SIS Software version 3.3.0K183019 · 510(k) | Surgical Information Sciences, Inc. | Radiology | LLZ | database entry | |
| KardiaAIK181823 · 510(k) | AliveCor, Inc. | Cardiovascular | DQK | database entry | |
| cmTriageK183285 · 510(k) | CureMetrix, Inc | Radiology | QFM | database entry | |
| RhythmAnalyticsK182344 · 510(k) | Biofourmis Singapore Pte. Ltd. | Cardiovascular | DQK | database entry | |
| RX-1 Rhythm Express Remote Cardiac Monitoring SyK183704 · 510(k) | VivaQuant Inc. | Cardiovascular | DXH | database entry | |
| d-Nav SystemK181916 · 510(k) | Hygieia, Inc | Anesthesiology | NDC | database entry | |
| AI Rad CompanionK183272 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | LLZ | database entry | |
| SIGNA PremierK183231 · 510(k) | GE Medical Systems, LLC | Radiology | LNH | database entry | |
| Study WatchK182456 · 510(k) | Verily Life Sciences LLC | Cardiovascular | DXH | database entry | |
| MRCP+ v1.0K183133 · 510(k) | Perspectum Diagnostics Ltd | Radiology | LLZ | database entry |
Every year in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.