114 devices · 87 companies · 2020
AI-enabled medical devices FDA authorized in 2020
114 devices authorized in 2020, 2020, from 87 companies across 30 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (112 of 114 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes authorized in 2020
- LLZ · System, Image Processing, Radiological21
- JAK · System, X-Ray, Tomography, Computed13
- QAS · Radiological Computer-Assisted Triage And Notification Software12
- QIH · Automated Radiological Image Processing Software11
- LNH · System, Nuclear Magnetic Resonance Imaging8
- IYN · System, Imaging, Pulsed Doppler, Ultrasonic7
- QKB · Radiological Image Processing Software For Radiation Therapy4
- QFM · Radiological Computer-Assisted Prioritization Software For Lesions4
- QDQ · Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer3
- MUJ · System, Planning, Radiation Therapy Treatment3
- QJU · Image Acquisition And/Or Optimization Guided By Artificial Intelligence3
- KPS · System, Tomography, Computed, Emission3
- POK · Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer2
- DQK · Computer, Diagnostic, Programmable2
- JOY · Device, Automated Cell-Locating2
- OEB · Lung Computed Tomography System, Computer-Aided Detection2
- POV · Semen Analysis Device1
- DQD · Stethoscope, Electronic1
- PRH · Positive Blood Culture Identification And Ast Kit1
- QEA · Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid1
- MLO · Electrocardiograph, Ambulatory, With Analysis Algorithm1
- PIB · Diabetic Retinopathy Detection Device1
- QBS · Radiological Computer Assisted Detection/Diagnosis Software For Fracture1
- IYO · System, Imaging, Pulsed Echo, Ultrasonic1
- DSI · Detector And Alarm, Arrhythmia1
- DPS · Electrocardiograph1
- IYE · Accelerator, Linear, Medical1
- DXH · Transmitters And Receivers, Electrocardiograph, Telephone1
- MWI · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1
- BZG · Spirometer, Diagnostic1
Panels
Companies with more than one device here
- Siemens Medical Solutions USA, Inc.9
- Canon Medical Systems Corporation5
- Shanghai United Imaging Healthcare Co., Ltd.4
- Aidoc Medical, Ltd.3
- Zebra Medical Vision Ltd.3
- GE Medical Systems SCS3
- Coreline Soft Co., Ltd.3
- Caption Health3
- GE Medical Systems Ultrasound and Primary Care Diagnostics3
- GE Medical Systems, LLC2
- DiA Imaging Analysis Ltd2
- GE Medical Systems Ultrasound and2
- iSchemaView Inc.2
Every device, newest decision first
| Decision | Device | Company | Panel | Product code | FDA |
|---|---|---|---|---|---|
| BriefCaseK203508 · 510(k) | Aidoc Medical, Ltd. | Radiology | QAS | database entry | |
| AI MetricsK202229 · 510(k) | AI Metrics, LLC | Radiology | LLZ | database entry | |
| EchoGo ProK201555 · 510(k) | Ultromics Ltd | Radiology | POK | database entry | |
| Aquilion Exceed LBK203042 · 510(k) | Canon Medical Systems Corporation | Radiology | JAK | database entry | |
| Deep Learning Image Reconstruction for GemstoneK201745 · 510(k) | GE Medical Systems, LLC | Radiology | JAK | database entry | |
| HepaFat-AIK201039 · 510(k) | Resonance Health Analysis Services Pty Ltd | Radiology | LNH | database entry | |
| HealthJOINTK202487 · 510(k) | Zebra Medical Vision Ltd. | Radiology | LLZ | database entry | |
| Revolution AscendK203169 · 510(k) | GE Healthcare Japan Corporation | Radiology | JAK | database entry | |
| CorInsights MRIK193287 · 510(k) | ADM Diagnostics, Inc. | Radiology | LLZ | database entry | |
| HALOK200873 · 510(k) | NICo-Lab B.V. | Radiology | QAS | database entry | |
| Genius AI DetectionK201019 · 510(k) | Hologic, Inc. | Radiology | QDQ | database entry | |
| syngo.via MI Workflows, syngo MBFK201195 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | QIH | database entry | |
| PROViewK193306 · 510(k) | GE Medical Systems SCS | Radiology | LLZ | database entry | |
| FastStroke, CT Perfusion 4DK193289 · 510(k) | GE Medical Systems SCS | Radiology | JAK | database entry | |
| KardiaAIK201985 · 510(k) | AliveCor, Inc. | Cardiovascular | DQK | database entry | |
| AI-Rad Companion Organs RTK193562 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | QKB | database entry | |
| Neuro.Al AlgorithmK200750 · 510(k) | TeraRecon, Inc. | Radiology | LLZ | database entry | |
| WRDensity by Whiterabbit.aiK202013 · 510(k) | Whiterabbit.ai Inc. | Radiology | QIH | database entry | |
| AutoContourK200323 · 510(k) | Radformation, Inc. | Radiology | QKB | database entry | |
| LensHooke X1 PRO Semen Quality Analyzer, LensHooK202089 · 510(k) | Bonraybio Co., Ltd. | Hematology | POV | database entry | |
| A View LCSK201710 · 510(k) | Coreline Soft Co., Ltd. | Radiology | LLZ | database entry | |
| CellaVision DC-1, CellaVision DC-1 PPAK200595 · 510(k) | CellaVision AB | Hematology | JOY | database entry | |
| SIGNA 7.0TK201615 · 510(k) | GE Medical Systems, LLC | Radiology | LNH | database entry | |
| Quantib ProstateK202501 · 510(k) | Quantib BV | Radiology | LLZ | database entry | |
| Stethee Pro 1, Stethee Pro Software SystemK193631 · 510(k) | M3DICINE Pty Ltd. | Cardiovascular | DQD | database entry | |
| Cleerly Labs v2.0K202280 · 510(k) | Cleerly, Inc. | Radiology | LLZ | database entry | |
| LiverMultiScanK202170 · 510(k) | Perspectum LTD | Radiology | LNH | database entry | |
| X100 with Full Field Peripheral Blood SmearK201301 · 510(k) | Scopio Labs LTD. | Hematology | JOY | database entry | |
| THINQK192051 · 510(k) | CorticoMetrics LLC | Radiology | LLZ | database entry | |
| LVivo SeamlessK202546 · 510(k) | DiA Imaging Analysis Ltd | Radiology | QIH | database entry | |
| Xeleris V Processing and Review SystemsK201103 · 510(k) | GE Healthcare | Radiology | LLZ | database entry | |
| RayStationK200569 · 510(k) | RaySearch Laboratories AB (publ) | Radiology | MUJ | database entry | |
| Caption GuidanceK201992 · 510(k) | Caption Health | Radiology | QJU | database entry | |
| EchoPAC Software Only, EchoPAC Plug-InK200852 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | LLZ | database entry | |
| AVAK201369 · 510(k) | See-Mode Technologies Pte. Ltd. | Radiology | LLZ | database entry | |
| VX1K201298 · 510(k) | Volta Medical | Cardiovascular | DQK | database entry | |
| Accelerate Pheno System, Accelerate PhenoTest BCK192665 · 510(k) | Accelerate Diagnostics, Inc. | Microbiology | PRH | database entry | |
| Vivid iqK200708 · 510(k) | GE Medical Systems Ultrasound and | Radiology | IYN | database entry | |
| Vivid T8, Vivid T9K200851 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN | database entry | |
| EyeBOXK201841 · 510(k) | Oculogica, Inc. | Neurology | QEA | database entry | |
| SIGNA ArtistK202238 · 510(k) | GE Healthcare (Tianjin) Company Limited | Radiology | LNH | database entry | |
| RX-1 Rhythm Express Remote Cardiac Monitoring SyK200833 · 510(k) | VivaQuant Inc. | Cardiovascular | MLO | database entry | |
| BriefCaseK201020 · 510(k) | Aidoc Medical, Ltd. | Radiology | QAS | database entry | |
| AVIEWK200714 · 510(k) | Coreline Soft Co., Ltd | Radiology | LLZ | database entry | |
| TOMTEC-ARENAK201632 · 510(k) | TOMTEC Imaging Systems GmbH | Radiology | LLZ | database entry | |
| Syngo.via RT Image SuiteK201444 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | MUJ | database entry | |
| Limbus ContourK201232 · 510(k) | Limbus AI Inc. | Radiology | LLZ | database entry | |
| VIDAvisionK200990 · 510(k) | VIDA Diagnostics Inc. | Radiology | JAK | database entry | |
| AccipiolxK201310 · 510(k) | MaxQ Al Ltd. | Radiology | QAS | database entry | |
| HYPER DLRK193210 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | KPS | database entry | |
| EyeArtK200667 · 510(k) | Eyenuk, Inc | Ophthalmic | PIB | database entry | |
| FractureDetectK193417 · 510(k) | Imagen Technologies, Inc. | Radiology | QBS | database entry | |
| AI-Rad Companion Prostate MRK193283 · 510(k) | Siemens Medical Solutions USA Inc. | Radiology | QIH | database entry | |
| Vivid E80/ Vivid E90/ Vivid E95K200743 · 510(k) | GE Medical Systems Ultrasound and | Radiology | IYN | database entry | |
| Caption Interpretation Automated Ejection FractiK200621 · 510(k) | Caption Health | Radiology | QIH | database entry | |
| Vivid S60N, Vivid S70NK200497 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN | database entry | |
| HealthMammoK200905 · 510(k) | Zebra Medical Vision Ltd. | Radiology | QFM | database entry | |
| Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE RecK193097 · 510(k) | Canon Medical Systems Corporation | Radiology | LNH | database entry | |
| AI-Rad Companion EngineK193294 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | LLZ | database entry | |
| Ezra Plexo SoftwareK192969 · 510(k) | Ezra AI Inc. | Radiology | QIH | database entry | |
| Rapid LVOK200941 · 510(k) | iSchemaView Inc. | Radiology | QAS | database entry | |
| Deep ReconK193073 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | JAK | database entry | |
| Contour ProtegeAIK193252 · 510(k) | MIM Software Inc. | Radiology | QKB | database entry | |
| InferRead Lung CT.AIK192880 · 510(k) | Beijing Infervision Technology Co.,Ltd. | Radiology | OEB | database entry | |
| Rapid ASPECTSK200760 · 510(k) | iSchemaView Inc. | Radiology | POK | database entry | |
| CINAK200855 · 510(k) | AVICENNA.AI | Radiology | QAS | database entry | |
| LVivo Software ApplicationK200232 · 510(k) | DiA Imaging Analysis Ltd | Radiology | QIH | database entry | |
| BriefCaseK193298 · 510(k) | Aidoc Medical, Ltd. | Radiology | QAS | database entry | |
| qERK200921 · 510(k) | Qure.ai Technologies | Radiology | QAS | database entry | |
| AI-Rad Companion Brain MRK193290 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | LLZ | database entry | |
| MEDO ARIAK200356 · 510(k) | Medo.ai | Radiology | QIH | database entry | |
| Auto 3D Bladder Volume ToolK200980 · 510(k) | Butterfly Network, Inc. | Radiology | IYO | database entry | |
| QLAB Advanced Quantification SoftwareK200974 · 510(k) | Philips Healthcare | Radiology | QIH | database entry | |
| uWS-MRK192601 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd | Radiology | QIH | database entry | |
| Syngo.CT CaScoringK201034 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | JAK | database entry | |
| HealthVCFK192901 · 510(k) | Zebra Medical Vision Ltd. | Radiology | QFM | database entry | |
| uMR 780K193176 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd | Radiology | LNH | database entry | |
| AVIEW LCSK193220 · 510(k) | Coreline Soft Co., Ltd | Radiology | LLZ | database entry | |
| EPIQ Diagnostic Ultrasound System Series, AffiniK201012 · 510(k) | Philips Ultrasound, Inc. | Radiology | IYN | database entry | |
| NinesAIK193351 · 510(k) | Nines, Inc. | Radiology | QAS | database entry | |
| Caption GuidanceK200755 · 510(k) | Caption Health | Radiology | QJU | database entry | |
| CuraRad-ICHK192167 · 510(k) | CuraCloud Corp. | Radiology | QAS | database entry | |
| SIGNA PremierK193282 · 510(k) | GE Healthcare (GE Medical Systems, LLC) | Radiology | LNH | database entry | |
| AIMI-Triage CXR PTXK193300 · 510(k) | RADLogics, Inc. | Radiology | QFM | database entry | |
| Rapid ICHK193087 · 510(k) | iSchemaView Incorporated | Radiology | QAS | database entry | |
| KOSMOSK193518 · 510(k) | EchoNous, Inc. | Radiology | IYN | database entry | |
| BodyGuardian Remote Monitoring SystemK192732 · 510(k) | Preventice Technologies, Inc. | Cardiovascular | DSI | database entry | |
| Arterys MICAK192437 · 510(k) | Arterys Inc. | Radiology | QIH | database entry | |
| MammoScreenK192854 · 510(k) | Therapixel | Radiology | QDQ | database entry | |
| Hepatic VCARK193281 · 510(k) | GE Medical Systems SCS | Radiology | JAK | database entry | |
| AI-ECG TrackerK200036 · 510(k) | Shenzhen Carewell Electronics Co., Ltd. | Cardiovascular | DPS | database entry | |
| Viz ICHK193658 · 510(k) | Viz.ai, Inc. | Radiology | QAS | database entry | |
| Al-Rad CompanionK193267 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | JAK | database entry | |
| SonoVision Ultrasound Imaging SystemK192388 · 510(k) | Tissue Differentiation Intelligence, LLC | Radiology | IYN | database entry | |
| syngo.CT Lung CADK193216 · 510(k) | Siemens Medical Solutions, Inc | Radiology | OEB | database entry | |
| Vantage Galan 3T, MRT-3020, V6.0 with AiCE ReconK192574 · 510(k) | Canon Medical Systems Corporation | Radiology | LNH | database entry | |
| TransparaK193229 · 510(k) | ScreenPoint Medical B.V. | Radiology | QDQ | database entry | |
| BroncholabK191550 · 510(k) | Fluidda Inc. | Radiology | JAK | database entry | |
| icobrain-ctpK192962 · 510(k) | Icometrix NV | Radiology | LLZ | database entry | |
| Red DotK191556 · 510(k) | Behold.AI Technologies Limited | Radiology | QFM | database entry | |
| AccuContourK191928 · 510(k) | Xiamen Manteia Technology LTD. | Radiology | QKB | database entry | |
| Aquilion Prime SPK192832 · 510(k) | Canon Medical Systems Corporation | Radiology | JAK | database entry | |
| densitas densityaiK192973 · 510(k) | Densitas, Inc. | Radiology | LLZ | database entry | |
| Biograph Vision, Biograph mCT Family of PET/CTsK193248 · 510(k) | Siemens Medical Solutions USA, Inc | Radiology | KPS | database entry | |
| Aquilion ONEK192828 · 510(k) | Canon Medical Systems Corporation | Radiology | JAK | database entry | |
| Biograph HorizonK193178 · 510(k) | Siemens Medical Solution USA, Inc. | Radiology | KPS | database entry | |
| Ethos Treatment Management, Ethos Treatment PlanK192377 · 510(k) | Varian Medical Systems, Inc. | Radiology | IYE | database entry | |
| Caption GuidanceDEN190040 · De Novo | Bay Labs, Inc. | Radiology | QJU | database entry | |
| MRCAT brainK193109 · 510(k) | Philips Medical Systems MR Finland | Radiology | MUJ | database entry | |
| Study Watch with Irregular Pulse MonitorK192415 · 510(k) | Verily Life Sciences LLC | Cardiovascular | DXH | database entry | |
| Auto PositioningK192956 · 510(k) | GE Hangwei Medical Systems, Co., Ltd. | Radiology | JAK | database entry | |
| ADAS 3DK191125 · 510(k) | Galgo Medical S.L | Radiology | LLZ | database entry | |
| Eko Analysis SoftwareK192004 · 510(k) | Eko Devices Inc | Cardiovascular | MWI | database entry | |
| Air NextK183089 · 510(k) | NuvoAir AB | Anesthesiology | BZG | database entry |
Every year in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.