129 devices · 104 companies · 2021
AI-enabled medical devices FDA authorized in 2021
129 devices authorized in 2021, 2021, from 104 companies across 33 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (124 of 129 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes authorized in 2021
- QIH · Automated Radiological Image Processing Software19
- LLZ · System, Image Processing, Radiological16
- QKB · Radiological Image Processing Software For Radiation Therapy9
- JAK · System, X-Ray, Tomography, Computed9
- IYN · System, Imaging, Pulsed Doppler, Ultrasonic9
- LNH · System, Nuclear Magnetic Resonance Imaging8
- MUJ · System, Planning, Radiation Therapy Treatment6
- QDQ · Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer5
- QFM · Radiological Computer-Assisted Prioritization Software For Lesions5
- QAS · Radiological Computer-Assisted Triage And Notification Software5
- KPS · System, Tomography, Computed, Emission5
- OWB · Interventional Fluoroscopic X-Ray System3
- QNP · Gastrointesinal Lesion Software Detection System3
- POK · Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer2
- QNV · Adjunctive Hemodynamic Indicator With Decision Point2
- DQK · Computer, Diagnostic, Programmable2
- MQB · Solid State X-Ray Imager (Flat Panel/Digital Imager)2
- MYN · Analyzer, Medical Image2
- QME · Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate2
- NQQ · System, Imaging, Optical Coherence Tomography (Oct)2
- PCS · Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox1
- QDB · Photoplethysmograph Analysis Software For Over-The-Counter Use1
- QEA · Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid1
- QPN · Software Algorithm Device To Assist Users In Digital Pathology1
- OLZ · Automatic Event Detection Software For Polysomnograph With Electroencephalograph1
- MXD · Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)1
- PIB · Diabetic Retinopathy Detection Device1
- QPF · Pediatric Autism Spectrum Disorder Diagnosis Aid1
- QOK · Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate1
- OEB · Lung Computed Tomography System, Computer-Aided Detection1
- QNK · Optoacoustic Imaging System1
- QNL · Medium-Term Adjunctive Predictive Cardiovascular Indicator1
- PJA · Coronary Vascular Physiologic Simulation Software1
Panels
Companies with more than one device here
- Canon Medical Systems Corporation7
- Siemens Medical Solutions USA, Inc.5
- GE Medical Systems, LLC4
- Vysioneer Inc.3
- Samsung Medison Co., Ltd.3
- Qure.ai Technologies2
- Zebra Medical Vision Ltd.2
- DiA Imaging Analysis Ltd2
- Fifth Eye Inc.2
- Lunit Inc.2
- Subtle Medical, Inc.2
- Philips Medical Systems2
- ClariPi Inc.2
- RaySearch Laboratories AB (publ)2
- Varian Medical Systems, Inc.2
- Shanghai United Imaging Healthcare Co., Ltd.2
- Cosmo Artificial Intelligence - AI Ltd2
- Oxehealth Limited2
- iCAD, Inc.2
Every device, newest decision first
| Decision | Device | Company | Panel | Product code | FDA |
|---|---|---|---|---|---|
| LiverSmartK213776 · 510(k) | Resonance Health Analysis Services Pty Ltd | Radiology | PCS | database entry | |
| BoneMRIK202404 · 510(k) | MRIguidance B.V | Radiology | QIH | database entry | |
| qXR-BTK212690 · 510(k) | Qure.ai Technologies | Radiology | QIH | database entry | |
| BU-CADK210670 · 510(k) | TaiHao Medical Inc. | Radiology | QDQ | database entry | |
| EchoGo CoreK213275 · 510(k) | Ultromics Limited | Radiology | QIH | database entry | |
| VBrainK213628 · 510(k) | Vysioneer Inc. | Radiology | QKB | database entry | |
| Koios DSK212616 · 510(k) | Koios Medical, Inc. | Radiology | POK | database entry | |
| RT-Mind-AIK213155 · 510(k) | MedMind Technology Co., Ltd. | Radiology | QKB | database entry | |
| HealthPPTK211803 · 510(k) | Zebra Medical Vision Ltd. | Radiology | QFM | database entry | |
| LVivo SeamlessK212466 · 510(k) | DiA Imaging Analysis Ltd | Radiology | QIH | database entry | |
| Al-Rad CompanionK213096 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | JAK | database entry | |
| AHI SystemK212219 · 510(k) | Fifth Eye Inc. | Cardiovascular | QNV | database entry | |
| Cydar EVK212442 · 510(k) | Cydar Ltd. | Radiology | OWB | database entry | |
| Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE RK213305 · 510(k) | Canon Medical Systems Corporation | Radiology | LNH | database entry | |
| MammoScreen 2.0K211541 · 510(k) | Therapixel | Radiology | QDQ | database entry | |
| OnQ NeuroK210831 · 510(k) | CorTechs Labs, Inc | Radiology | QIH | database entry | |
| EndoScreenerK211326 · 510(k) | Chengdu Wision Medical Device Co., LTD. | Gastroenterology-Urology | QNP | database entry | |
| Swoop Point-of-Care Magnetic Resonance ImagingK212456 · 510(k) | Hyperfine, Inc. | Radiology | LNH | database entry | |
| Soteria.AIK212336 · 510(k) | Omega Medical Imaging, LLC | Radiology | OWB | database entry | |
| Lunit INSIGHT MMGK211678 · 510(k) | Lunit Inc. | Radiology | QDQ | database entry | |
| TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 ElK212265 · 510(k) | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | Radiology | IYN | database entry | |
| Clarius Ultrasound ScannerK213436 · 510(k) | Clarius Mobile Health Corp. | Radiology | IYN | database entry | |
| Lunit INSIGHT CXR TriageK211733 · 510(k) | Lunit Inc. | Radiology | QFM | database entry | |
| IM007K210543 · 510(k) | Implicity, Inc. | Cardiovascular | DQK | database entry | |
| Critical Care Suite with Endotracheal Tube PositK211161 · 510(k) | GE Medical Systems, LLC | Radiology | QIH | database entry | |
| Advanced Algorithms for Treatment Management AppK212218 · 510(k) | Elekta Solutions AB | Radiology | QKB | database entry | |
| FlightPlan for LiverK210807 · 510(k) | GE Medical Systems SCS | Radiology | LLZ | database entry | |
| IRNF AppK212516 · 510(k) | Apple Inc. | Cardiovascular | QDB | database entry | |
| Contour ProtegeAIK210632 · 510(k) | MIM Software Inc. | Radiology | QKB | database entry | |
| SwiftMRK210999 · 510(k) | AIRS Medical Inc. | Radiology | LLZ | database entry | |
| StrokeSENS LVOK212261 · 510(k) | Circle Neurovascular Imaging, Inc | Radiology | QAS | database entry | |
| VBrain-OARK212116 · 510(k) | Vysioneer Inc. | Radiology | QKB | database entry | |
| EYE-SYNCK202927 · 510(k) | SyncThink, Inc. | Neurology | QEA | database entry | |
| SubtlePETK211964 · 510(k) | Subtle Medical, Inc. | Radiology | KPS | database entry | |
| Philips EPIQ Diagnostic Ultrasound System, PhiliK212704 · 510(k) | Philips Medical Systems | Radiology | IYN | database entry | |
| Paige ProstateDEN200080 · De Novo | Paige.AI | Pathology | QPN | database entry | |
| Deep Learning Image ReconstructionK212067 · 510(k) | GE Healthcare Japan Corporation | Radiology | JAK | database entry | |
| Intelligent NRK212269 · 510(k) | Canon Inc. | Radiology | MQB | database entry | |
| HealthCCSngK210085 · 510(k) | Zebra Medical Vision Ltd. | Radiology | JAK | database entry | |
| ClariSIGMAMK203785 · 510(k) | ClariPi Inc. | Radiology | QIH | database entry | |
| Versana PremierK210438 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | IYN | database entry | |
| Aquilion Exceed LBK211828 · 510(k) | Canon Medical Systems Corporation | Radiology | JAK | database entry | |
| HERA W9, HERA W10 Diagnostic Ultrasound SystemK211824 · 510(k) | Samsung Medison Co., Ltd. | Radiology | IYN | database entry | |
| V8 Diagnostic Ultrasound SystemK211945 · 510(k) | Samsung Medison CO., LTD. | Radiology | IYN | database entry | |
| AmCAD-UTK203555 · 510(k) | AmCad BioMed Corporation | Radiology | QIH | database entry | |
| EPIQ Series Diagnostic Ultrasound System, AffiniK211597 · 510(k) | Philips Medical Systems | Radiology | IYN | database entry | |
| RayStation 11.0K211867 · 510(k) | RaySearch Laboratories AB (publ) | Radiology | MUJ | database entry | |
| AI SegmentationK211881 · 510(k) | Varian Medical Systems, Inc. | Radiology | MUJ | database entry | |
| Auto Lung Nodule DetectionK201560 · 510(k) | Samsung Electronics Co.,Ltd. | Radiology | MYN | database entry | |
| EndoNautK212383 · 510(k) | Therenva SAS | Radiology | OWB | database entry | |
| RBkneeK203696 · 510(k) | Radiobotics ApS | Radiology | LLZ | database entry | |
| Discovery MI Gen2K211846 · 510(k) | GE Medical Systems, LLC. | Radiology | KPS | database entry | |
| TruSPECT Radiological Image Processing StationK212230 · 510(k) | Spectrum Dynamics Medical Ltd | Radiology | LLZ | database entry | |
| InferRead CT Stroke.AIK211179 · 510(k) | Infervision Medical Technology Co., Ltd. | Radiology | QAS | database entry | |
| uCT ATLAS with uWS-CT-Dual Energy AnalysisK203448 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | JAK | database entry | |
| Vereos PET/CTK211764 · 510(k) | Philips Medical Systems Nederland B.V. | Radiology | KPS | database entry | |
| KosmosK212100 · 510(k) | EchoNous, Inc. | Radiology | IYN | database entry | |
| breastscape v1.0K211431 · 510(k) | Olea Medical | Radiology | QIH | database entry | |
| qER-QuantK211222 · 510(k) | Qure.ai Technologies | Radiology | QIH | database entry | |
| syngo.via RT Image SuiteK211379 · 510(k) | Siemens Medical Solutions USA Inc. | Radiology | MUJ | database entry | |
| aPROMISEK211655 · 510(k) | EXINI Diagnostics AB | Radiology | LLZ | database entry | |
| ClariCT.AIK212074 · 510(k) | ClariPi Inc. | Radiology | LLZ | database entry | |
| Volpara Imaging SoftwareK211279 · 510(k) | Volpara Health Technologies Limited | Radiology | LLZ | database entry | |
| Us2.v1K210791 · 510(k) | eko.ai Pte. Ltd. d/b/a Us2.ai | Radiology | QIH | database entry | |
| GI GeniusK211951 · 510(k) | Cosmo Artificial Intelligence - AI Ltd | Gastroenterology-Urology | QNP | database entry | |
| Vital SignsK211906 · 510(k) | Oxehealth Limited | Cardiovascular | QME | database entry | |
| Chest-CADK210666 · 510(k) | Imagen Technologies, Inc | Radiology | MYN | database entry | |
| Change Healthcare Anatomical AIK210719 · 510(k) | Change Healthcare Canada Company | Radiology | QIH | database entry | |
| PowerLook Density Assessment V4.0K211506 · 510(k) | iCAD, Inc. | Radiology | QIH | database entry | |
| HALOK211788 · 510(k) | Nico.Lab B.V. | Radiology | QAS | database entry | |
| MAGNETOM Free.MaxK210611 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | LNH | database entry | |
| RayStation 10.1K210645 · 510(k) | RaySearch Laboratories AB (publ) | Radiology | MUJ | database entry | |
| Precise PositionK203514 · 510(k) | Philips Healthcare (Suzhou) Co., Ltd. | Radiology | JAK | database entry | |
| Qmenta Care Platform FamilyK202718 · 510(k) | Mint Labs, Inc., d/b/a. QMENTA | Radiology | LLZ | database entry | |
| EnsoSleepK210034 · 510(k) | EnsoData, Inc. | Neurology | OLZ | database entry | |
| LINQ II Insertable Cardiac Monitor, Zelda AI ECGK210484 · 510(k) | Medtronic, Inc. | Cardiovascular | MXD | database entry | |
| IDx-DRK203629 · 510(k) | Digital Diagnostics Inc. | Ophthalmic | PIB | database entry | |
| syngo.via MI WorkFlows, Scenium, syngo MBFK211459 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | QIH | database entry | |
| OPTIS Mobile Next Imaging System, OPTIS IntegratK210458 · 510(k) | Abbott Medical | Radiology | NQQ | database entry | |
| Cognoa ASD Diagnosis AidDEN200069 · De Novo | Cognoa, Inc. | Neurology | QPF | database entry | |
| Transpara 1.7.0K210404 · 510(k) | ScreenPoint Medical B.V. | Radiology | QDQ | database entry | |
| Zio ECG Utilization SoftwareK202527 · 510(k) | iRhythm Technologies, Inc. | Cardiovascular | DQK | database entry | |
| CINA CHESTK210237 · 510(k) | Avicenna.AI | Radiology | QAS | database entry | |
| Overjet Dental AssistK210187 · 510(k) | Overjet, Inc. | Radiology | LLZ | database entry | |
| SIGNA 7.0TK211118 · 510(k) | GE Medical Systems, LLC | Radiology | LNH | database entry | |
| HS40 Diagnostic Ultrasound SystemK210426 · 510(k) | Samsung Medison CO., LTD. | Radiology | IYN | database entry | |
| HYPER AiRK210001 · 510(k) | Shanghai United Imaging Healthcare Co.,Ltd. | Radiology | KPS | database entry | |
| Cartesion PrimeK203314 · 510(k) | Canon Medical Systems Corporation | Radiology | KPS | database entry | |
| MEDO-ThyroidK203502 · 510(k) | MEDO DX Pte. Ltd. | Radiology | QIH | database entry | |
| Preview ShoulderK210556 · 510(k) | Genesis Software Innovations | Radiology | QIH | database entry | |
| Automatic Anatomy RecognitionK203610 · 510(k) | Quantitative Radiology Solutions, LLC | Radiology | QKB | database entry | |
| AI SegmentationK203469 · 510(k) | Varian Medical Systems, Inc. | Radiology | MUJ | database entry | |
| Saige-QK203517 · 510(k) | DeepHealth, Inc. | Radiology | QFM | database entry | |
| BriefCase, RIB Fractures TriageK202992 · 510(k) | Aidoc Medical, Ltd. | Radiology | QFM | database entry | |
| GI GeniusDEN200055 · De Novo | Cosmo Artificial Intelligence - AI, LTD | Gastroenterology-Urology | QNP | database entry | |
| DV. TargetK202928 · 510(k) | Deepvoxel INC | Radiology | QKB | database entry | |
| Eclipse II with Smart Noise CancellationK202441 · 510(k) | Carestream Health, Inc. | Radiology | MQB | database entry | |
| Gili Pro BioSensorDEN200038 · De Novo | ContinUse Biometrics Ltd. | Cardiovascular | QOK | database entry | |
| SIS SystemK210071 · 510(k) | Surgical Information Sciences, Inc. | Radiology | LLZ | database entry | |
| syngo.CT Lung CADK203258 · 510(k) | Siemens Healthcare GmbH | Radiology | OEB | database entry | |
| MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MK203443 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | LNH | database entry | |
| Oxehealth Vital SignsDEN200019 · De Novo | Oxehealth Limited | Cardiovascular | QME | database entry | |
| Aquilion ONEK203225 · 510(k) | Canon Medical Systems Corporation | Radiology | JAK | database entry | |
| Viz ICHK210209 · 510(k) | Viz.ai, Inc. | Radiology | QAS | database entry | |
| VBrainK203235 · 510(k) | Vysioneer Inc. | Radiology | QKB | database entry | |
| OncospaceK202284 · 510(k) | Oncospace, Inc. | Radiology | MUJ | database entry | |
| ProFound AI Software V3.0K203822 · 510(k) | iCAD Inc. | Radiology | QDQ | database entry | |
| Imbio RV/LV SoftwareK203256 · 510(k) | Imbio, LLC | Radiology | QIH | database entry | |
| Optellum Virtual Nodule Clinic, Optellum softwarK202300 · 510(k) | Optellum Ltd | Radiology | POK | database entry | |
| Vantage Galan 3T, MRT-3020, V6.0 with AiCE ReconK203323 · 510(k) | Canon Medical Systems Corporation | Radiology | LNH | database entry | |
| MaxFOV 2K203617 · 510(k) | GE Medical Systems, LLC. | Radiology | JAK | database entry | |
| Analytic for Hemodynamic InstabilityDEN200022 · De Novo | Fifth Eye Inc. | Cardiovascular | QNV | database entry | |
| SubtleMRK203182 · 510(k) | Subtle Medical, Inc. | Radiology | LLZ | database entry | |
| NinesMeasureK202990 · 510(k) | Nines, Inc. | Radiology | LLZ | database entry | |
| OTIS 2.1 Optical Coherence Tomography System, THK203578 · 510(k) | Perimeter Medical Imaging AI, Inc. | Radiology | NQQ | database entry | |
| TruPlanK202212 · 510(k) | Circle Cardiovascular Imaging Inc. | Radiology | LLZ | database entry | |
| Synapse 3D, Synapse 3D Base Tools v6.1K203103 · 510(k) | Fujifilm Corporation | Radiology | LLZ | database entry | |
| LVivo Software ApplicationK210053 · 510(k) | DiA Imaging Analysis Ltd | Radiology | QIH | database entry | |
| QUIBIM Precision ProstateK203582 · 510(k) | QUIBIM S.L. | Radiology | LLZ | database entry | |
| Visage Breast DensityK201411 · 510(k) | Visage Imaging GmbH | Radiology | QIH | database entry | |
| Vantage Orian 1.5T, MRT-1550, V6.0K202767 · 510(k) | Canon Medical Systems Corporation | Radiology | LNH | database entry | |
| uAI EasyTriage-RibK193271 · 510(k) | Shanghai United Imaging Intelligence Co., Ltd. | Radiology | QFM | database entry | |
| ART-PlanK202700 · 510(k) | TheraPanacea | Radiology | QKB | database entry | |
| Hepatica v1K203280 · 510(k) | Perspectum Ltd. | Radiology | LNH | database entry | |
| Aquilion LightningK201836 · 510(k) | Canon Medical Systems Corporation | Radiology | JAK | database entry | |
| Imagio Breast Imaging SystemP200003 · PMA | Seno Medical Instruments, Inc. | Radiology | QNK | database entry | |
| CLEWICU SystemK200717 · 510(k) | CLEW Medical Ltd. | Cardiovascular | QNL | database entry | |
| HeartFlow AnalysisK203329 · 510(k) | HeartFlow, Inc. | Cardiovascular | PJA | database entry | |
| BrainInsightK202414 · 510(k) | Hyperfine Research, Inc | 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.