162 devices · 116 companies · 2022
AI-enabled medical devices FDA authorized in 2022
162 devices authorized in 2022, 2022, from 116 companies across 35 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (153 of 162 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes authorized in 2022
- QIH · Automated Radiological Image Processing Software25
- LNH · System, Nuclear Magnetic Resonance Imaging18
- IYN · System, Imaging, Pulsed Doppler, Ultrasonic16
- JAK · System, X-Ray, Tomography, Computed15
- QAS · Radiological Computer-Assisted Triage And Notification Software15
- LLZ · System, Image Processing, Radiological12
- QFM · Radiological Computer-Assisted Prioritization Software For Lesions9
- QKB · Radiological Image Processing Software For Radiation Therapy7
- MYN · Analyzer, Medical Image5
- MUJ · System, Planning, Radiation Therapy Treatment5
- DQK · Computer, Diagnostic, Programmable4
- QDQ · Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer4
- PIB · Diabetic Retinopathy Detection Device2
- PJA · Coronary Vascular Physiologic Simulation Software2
- DQD · Stethoscope, Electronic2
- QBS · Radiological Computer Assisted Detection/Diagnosis Software For Fracture2
- POK · Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer1
- MKJ · Automated External Defibrillators (Non-Wearable)1
- OWB · Interventional Fluoroscopic X-Ray System1
- QRG · Ultrasound Guided Nerve Block Assist1
- BXQ · Rhinoanemometer (Measurement Of Nasal Decongestion)1
- OLZ · Automatic Event Detection Software For Polysomnograph With Electroencephalograph1
- MXD · Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)1
- QNP · Gastrointesinal Lesion Software Detection System1
- KGI · Densitometer, Bone1
- DXH · Transmitters And Receivers, Electrocardiograph, Telephone1
- QNV · Adjunctive Hemodynamic Indicator With Decision Point1
- JIR · Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)1
- QPF · Pediatric Autism Spectrum Disorder Diagnosis Aid1
- QDB · Photoplethysmograph Analysis Software For Over-The-Counter Use1
- JOY · Device, Automated Cell-Locating1
- QME · Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate1
- GKZ · Counter, Differential Cell1
- IZL · System, X-Ray, Mobile1
- MQB · Solid State X-Ray Imager (Flat Panel/Digital Imager)1
Panels
Companies with more than one device here
- Siemens Medical Solutions USA, Inc.15
- Aidoc Medical, Ltd.10
- GE Medical Systems Ultrasound and Primary Care Diagnostics,6
- Hyperfine, Inc.5
- Canon Medical Systems Corporation5
- Ever Fortune AI Co., Ltd.4
- Viz.ai, Inc.4
- iSchemaView Inc.3
- Samsung Medison Co., Ltd.3
- Coreline Soft Co.,Ltd.2
- Philips Healthcare (Suzhou) Co., Ltd2
- Overjet Inc.2
- DeepHealth, Inc.2
- Siemens Healthcare GmBh2
- 3D-Side SA2
- GE Healthcare Japan Corporation2
- GE Medical Systems2
- Philips Medical Systems Nederland B.V.2
- GE Healthcare2
- GE Healthcare(Tianjin) Company Limited2
The newest 150 devices
162 devices authorized in 2022 is more than one table should carry. The 150 newest decisions are below; every device has a page of its own, reached through the product-code and year lists above.
| Decision | Device | Company | Panel | Product code | FDA |
|---|---|---|---|---|---|
| AVIEWK214036 · 510(k) | Coreline Soft Co.,Ltd. | Radiology | QIH | database entry | |
| MR 5300 and MR 7700 R11 MR SystemsK223442 · 510(k) | Philips Medical Systems Nederlands B.V. | Radiology | LNH | database entry | |
| Philips CT 3500K223311 · 510(k) | Philips Healthcare (Suzhou) Co., Ltd | Radiology | JAK | database entry | |
| Overjet Calculus AssistK220928 · 510(k) | Overjet Inc. | Radiology | MYN | database entry | |
| BrainInsightK223268 · 510(k) | Hyperfine, Inc. | Radiology | QIH | database entry | |
| Saige-DensityK222275 · 510(k) | DeepHealth, Inc. | Radiology | QIH | database entry | |
| Swoop Portable MR Imaging SystemK223247 · 510(k) | Hyperfine, Inc. | Radiology | LNH | database entry | |
| BriefCaseK222692 · 510(k) | Aidoc Medical, Ltd. | Radiology | QFM | database entry | |
| STAR Apollo Mapping SystemK220786 · 510(k) | Rhythm Al, Ltd | Cardiovascular | DQK | database entry | |
| Avenda Health AI Prostate Cancer Planning SoftwaK221624 · 510(k) | Avenda Health, Inc. | Radiology | POK | database entry | |
| CINAK221716 · 510(k) | AVICENNA.AI | Radiology | QAS | database entry | |
| SIS SystemK223032 · 510(k) | Surgical Information Sciences, Inc. | Radiology | QIH | database entry | |
| BriefCaseK221330 · 510(k) | Aidoc Medical, Ltd. | Radiology | QAS | database entry | |
| BoneMRI v1.4K221762 · 510(k) | MRlguidance B.V. | Radiology | QIH | database entry | |
| Syngo DynamicsK222428 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | QIH | database entry | |
| AVIEW RT ACSK220408 · 510(k) | Coreline Soft Co.,Ltd | Radiology | QKB | database entry | |
| AEYE-DSK221183 · 510(k) | AEYE Health, Inc. | Ophthalmic | PIB | database entry | |
| EFAI ChestSuite XR Pneumothorax Assessment SysteK221552 · 510(k) | Ever Fortune AI Co., Ltd. | Radiology | QFM | database entry | |
| Avive Automated External DefibrillatorP210015 · PMA | Avive Solutions, Inc. | Cardiovascular | MKJ | database entry | |
| uMR Omega with uWS-MR-MRSK220332 · 510(k) | Shanghai United Imaging Healthcare Co.,Ltd. | Radiology | LNH | database entry | |
| EndoNautK222070 · 510(k) | Therenva SAS | Radiology | OWB | database entry | |
| Viz LVO ContaCTK223042 · 510(k) | Viz.ai, Inc. | Radiology | QAS | database entry | |
| AI-Rad CompanionK222361 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | JAK | database entry | |
| Spine CAMPK221632 · 510(k) | Medical Metrics, Inc. | Radiology | QIH | database entry | |
| ScanNav Anatomy Peripheral Nerve BlockDEN220024 · De Novo | Intelligent Ultrasound Limited | Anesthesiology | QRG | database entry | |
| HeartFlow AnalysisK213857 · 510(k) | HeartFlow, Inc. | Cardiovascular | PJA | database entry | |
| AI-Rad Companion Organs RTK221305 · 510(k) | Siemens Medical Solutions USA, Inc | Radiology | QKB | database entry | |
| BriefCaseK220709 · 510(k) | Aidoc Medical, Ltd. | Radiology | QAS | database entry | |
| Genius AI Detection 2.0K221449 · 510(k) | Hologic, Inc. | Radiology | QDQ | database entry | |
| VISIONAIRK221892 · 510(k) | PacificMD Biotech Llc | Anesthesiology | BXQ | database entry | |
| QIR SuiteK211611 · 510(k) | CASIS Cardiac Simulation & Imaging Software | Radiology | QIH | database entry | |
| CogNet QmTRIAGEK220080 · 510(k) | MedCognetics, Inc. | Radiology | QFM | database entry | |
| BriefCaseK222329 · 510(k) | Aidoc Medical, Ltd. | Radiology | QAS | database entry | |
| NS-HGlioK221738 · 510(k) | Neosoma Inc. | Radiology | QIH | database entry | |
| SomnoMetryK221179 · 510(k) | Neumetry Medical Inc | Neurology | OLZ | database entry | |
| Aorta-CADK213353 · 510(k) | Imagen Technologies, Inc | Radiology | MYN | database entry | |
| MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola FitK221733 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | LNH | database entry | |
| Rapid ICHK221456 · 510(k) | iSchemaView Inc. | Radiology | QAS | database entry | |
| Aquilion PrecisionK220986 · 510(k) | Canon Medical Systems Corporation | Radiology | JAK | database entry | |
| EFAI ChestSuite XR Pleural Effusion Assessment SK222076 · 510(k) | Ever Fortune.AI Co., Ltd. | Radiology | QFM | database entry | |
| syngo.via RT Image SuiteK220783 · 510(k) | Siemens Medical Solutions USA Inc. | Radiology | MUJ | database entry | |
| LiverMultiScan v5K213960 · 510(k) | Perspectum | Radiology | LNH | database entry | |
| DrAid for Radiology v1K221241 · 510(k) | VinBrain Joint Stock Company | Radiology | QFM | database entry | |
| Viz RV/LVK221100 · 510(k) | Viz.ai, Inc. | Radiology | QIH | database entry | |
| BriefCaseK222277 · 510(k) | Aidoc Medical, Ltd. | Radiology | QAS | database entry | |
| MRI PlannerK211841 · 510(k) | Spectronic Medical AB | Radiology | MUJ | database entry | |
| LINQ II Insertable Cardiac MonitorK221962 · 510(k) | Medtronic, Inc. | Cardiovascular | MXD | database entry | |
| AutoContour Model RADAC V2K220598 · 510(k) | Radformation, Inc. | Radiology | QKB | database entry | |
| HS40 Diagnostic Ultrasound SystemK221599 · 510(k) | Samsung Medison Co., Ltd. | Radiology | IYN | database entry | |
| MI View&GOK222172 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | QIH | database entry | |
| TeraRecon NeuroK220349 · 510(k) | TeraRecon, Inc | Radiology | LLZ | database entry | |
| SKOUT SoftwareK213686 · 510(k) | Iterative Scopes Inc. | Gastroenterology-Urology | QNP | database entry | |
| AI-Rad CompanionK213713 · 510(k) | Siemens Healthcare GmBh | Radiology | JAK | database entry | |
| ClearPoint Maestro Brain ModelK213645 · 510(k) | ClearPoint Neuro, Inc. | Radiology | QIH | database entry | |
| CustomizeK221432 · 510(k) | 3D-Side SA | Radiology | QIH | database entry | |
| Transpara 1.7.2K221347 · 510(k) | ScreenPoint Medical B.V. | Radiology | QDQ | database entry | |
| ABMD SoftwareK213760 · 510(k) | HeartLung Corporation | Radiology | KGI | database entry | |
| Deep Learning Image ReconstructionK220961 · 510(k) | GE Healthcare Japan Corporation | Radiology | JAK | database entry | |
| Swoop Portable MR Imaging SystemK221923 · 510(k) | Hyperfine, Inc. | Radiology | LNH | database entry | |
| cvi42 Auto Imaging Software ApplicationK213998 · 510(k) | Circle Cardiovascular Imaging Inc | Radiology | QIH | database entry | |
| DeepRhythmAIK210822 · 510(k) | Medicalgorithmics S.A. | Cardiovascular | DQK | database entry | |
| Viz SDHK220439 · 510(k) | Viz.ai, Inc. | Radiology | QAS | database entry | |
| EchoPAC Software Only, EchoPAC Plug-inK220940 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | QIH | database entry | |
| AI4CMR v1.0K220624 · 510(k) | AI4MedImaging Medical Solutions S.A. | Radiology | LLZ | database entry | |
| Vivid E80, Vivid E90, Vivid E95K220882 · 510(k) | GE Medical Systems Ultrasound and | Radiology | IYN | database entry | |
| Libby Echo:PrioK220956 · 510(k) | Dyad Medical, Inc | Radiology | QIH | database entry | |
| BrainInsightK220815 · 510(k) | Hyperfine, Inc. | Radiology | QIH | database entry | |
| ZEUS SystemK213409 · 510(k) | iRhythm Technologies, Inc. | Cardiovascular | DQK | database entry | |
| Study Watch with Irregular Pulse MonitorK213357 · 510(k) | Verily Life Sciences LLC | Cardiovascular | DXH | database entry | |
| Vivid iqK221148 · 510(k) | GE Medical Systems Ultrasound & Primary Care Diagnostics LLC | Radiology | IYN | database entry | |
| Vivid T8, Vivid T9K221147 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | IYN | database entry | |
| Vivid S60N, Vivid S70NK220619 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | IYN | database entry | |
| AHI SystemK221203 · 510(k) | Fifth Eye Inc. | Cardiovascular | QNV | database entry | |
| syngo.CT Extended FunctionalityK221727 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | JAK | database entry | |
| ProstatIDK212783 · 510(k) | ScanMed, LLC | Radiology | QDQ | database entry | |
| Minuteful - kidney testK210069 · 510(k) | Healthy.io Ltd. | Clinical Chemistry | JIR | database entry | |
| V8 Diagnostic Ultrasound System, V7 Diagnostic UK220975 · 510(k) | Samsung Medison Co., Ltd. | Radiology | IYN | database entry | |
| Eko Murmur Analysis SoftwareK213794 · 510(k) | Eko Devices, Inc. | Cardiovascular | DQD | database entry | |
| VenueK220851 · 510(k) | GE Medical Systems | Radiology | IYN | database entry | |
| Venue FitK220848 · 510(k) | GE Medical Systems | Radiology | IYN | database entry | |
| MAGNETOM Free.Max, MAGNETOM Free.StarK220575 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | LNH | database entry | |
| CoLumboK220497 · 510(k) | Smart Soft Healthcare AD | Radiology | QIH | database entry | |
| Venue GoK220800 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN | database entry | |
| IDx-DR v2.3K213037 · 510(k) | Digital Diagnostics Inc. | Ophthalmic | PIB | database entry | |
| ART-PLANK220813 · 510(k) | TheraPanacea | Radiology | QKB | database entry | |
| ElucidVivo A.3K221463 · 510(k) | Elucid Bioimaging Inc. | Radiology | LLZ | database entry | |
| Aquilion ONEK213504 · 510(k) | Canon Medical Systems Corporation | Radiology | JAK | database entry | |
| Swoop Portable MR Imaging SystemK221393 · 510(k) | Hyperfine, Inc. | Radiology | LNH | database entry | |
| EarliPoint SystemK213882 · 510(k) | EarliTec Diagnostics, Inc. | Neurology | QPF | database entry | |
| AIR Recon DLK213717 · 510(k) | GE Medical Systems,LLC (GE Healthcare) | Radiology | LNH | database entry | |
| Voluson Expert 22, Voluson Expert 20, Voluson ExK220358 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | IYN | database entry | |
| BriefCaseK221314 · 510(k) | Aidoc Medical, Ltd. | Radiology | QAS | database entry | |
| Atrial Fibrillation History FeatureK213971 · 510(k) | Apple Inc. | Cardiovascular | QDB | database entry | |
| RayvolveK220164 · 510(k) | AZmed SAS | Radiology | QBS | database entry | |
| Rapid LVOK221248 · 510(k) | iSchemaView Inc. | Radiology | QAS | database entry | |
| eMurmur Heart AIK220766 · 510(k) | CSD Labs GmbH | Cardiovascular | DQD | database entry | |
| SwiftMRK220416 · 510(k) | AIRS Medical Inc. | Radiology | LLZ | database entry | |
| BriefCaseK221240 · 510(k) | Aidoc Medical, Ltd. | Radiology | QAS | database entry | |
| Rapid PE Triage and NotificationK220499 · 510(k) | iSchemaView Inc. | Radiology | QAS | database entry | |
| syngo.CT CaScoringK221219 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | JAK | database entry | |
| Achieva, Ingenia, Ingenia CX, Ingenia Elition anK213583 · 510(k) | Philips Medical Systems Nederland B.V. | Radiology | LNH | database entry | |
| Quantib ProstateK221106 · 510(k) | Quantib BV | Radiology | LLZ | database entry | |
| MAGNETOM Skyra FitK220589 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | LNH | database entry | |
| Saige-DxK220105 · 510(k) | DeepHealth, Inc. | Radiology | QDQ | database entry | |
| Versana BalanceK220446 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | IYN | database entry | |
| Overjet Caries AssistK212519 · 510(k) | Overjet, Inc. | Radiology | MYN | database entry | |
| Segment 3DPrintK211966 · 510(k) | Medviso AB | Radiology | LLZ | database entry | |
| X100HT with Slide Loader with Full Field PeripheK220013 · 510(k) | Scopio Labs Ltd. | Hematology | JOY | database entry | |
| MVision AI SegmentationK212915 · 510(k) | MVision AI | Radiology | QKB | database entry | |
| MAGNETOM Lumina and MAGNETOM Vida Fit with syngoK220939 · 510(k) | Siemens Medical Solutions USA Inc. | Radiology | LNH | database entry | |
| Oxehealth Vital SignsK220899 · 510(k) | Oxehealth Limited | Cardiovascular | QME | database entry | |
| aPROMISE XK220590 · 510(k) | EXINI Diagnostics AB | Radiology | LLZ | database entry | |
| EFAI RTSuite CT HN-Segmentation SystemK220264 · 510(k) | Ever Fortune.AI Co., Ltd. | Radiology | QKB | database entry | |
| Philips Incisive CTK212441 · 510(k) | Philips Healthcare (Suzhou) Co., Ltd. | Radiology | JAK | database entry | |
| AliveCor QT ServiceK212662 · 510(k) | AliveCor, Inc. | Cardiovascular | DQK | database entry | |
| BriefCaseK213886 · 510(k) | Aidoc Medical, Ltd. | Radiology | QAS | database entry | |
| HealthOSTK213944 · 510(k) | NanoxAI Ltd. | Radiology | JAK | database entry | |
| Videa Caries AssistK213795 · 510(k) | VideaHealth, Inc | Radiology | MYN | database entry | |
| AI-Rad Companion Brain MRK213706 · 510(k) | Siemens Healthcare GmBh | Radiology | QIH | database entry | |
| RayStation 11BK220141 · 510(k) | RaySearch Laboratories AB (publ) | Radiology | MUJ | database entry | |
| Vantage Galan 3T, MRT-3020, V8.0 with AiCE ReconK220192 · 510(k) | Canon Medical Systems Corporation | Radiology | LNH | database entry | |
| INT ContourK212274 · 510(k) | Carina Medical LLC | Radiology | MUJ | database entry | |
| ClariPulmoK203783 · 510(k) | ClariPi Inc. | Radiology | LLZ | database entry | |
| HERA W10 Diagnostic Ultrasound System, HERA W9 DK220043 · 510(k) | Samsung Medison Co., LTD | Radiology | IYN | database entry | |
| MRCAT Head & NeckK214081 · 510(k) | Philips Oy | Radiology | MUJ | database entry | |
| EFAI Intelligent Cardiothoracic RatioK212624 · 510(k) | Ever Fortune. AI Co., Ltd. | Radiology | QIH | database entry | |
| MAGNETOM Avanto FitK220151 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | LNH | database entry | |
| DEEPVESSEL FFRK213657 · 510(k) | KeyaMed NA Inc. | Cardiovascular | PJA | database entry | |
| Aplio a550, Aplio a450, and Aplio a, DiagnosticK212960 · 510(k) | Canon Medical Systems Corporation | Radiology | IYN | database entry | |
| Athelas HomeK200828 · 510(k) | Athelas Inc. | Hematology | GKZ | database entry | |
| BriefCaseK213721 · 510(k) | Aidoc Medical, Ltd. | Radiology | QAS | database entry | |
| CustomizeK213779 · 510(k) | 3D-Side SA | Radiology | QIH | database entry | |
| BriefCaseK214043 · 510(k) | Aidoc Medical, Ltd. | Radiology | QFM | database entry | |
| Arterys MICAK203744 · 510(k) | Arterys Inc. | Radiology | QIH | database entry | |
| CardIQ SuiteK213725 · 510(k) | GE Medical Systems SCS | Radiology | JAK | database entry | |
| ClearRead Xray PneumothoraxK213566 · 510(k) | Riverain Technologies, Inc. | Radiology | QFM | database entry | |
| Second OpinionK210365 · 510(k) | Pearl Inc. | Radiology | MYN | database entry | |
| BoneViewK212365 · 510(k) | Gleamer | Radiology | QBS | database entry | |
| MAGNETOM Vida with syngo MR XA50AK213693 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | LNH | database entry | |
| Annalise Enterprise CXR Triage PneumothoraxK213941 · 510(k) | Annalise-AI | Radiology | QFM | database entry | |
| Viz ANEURYSM, Viz ANXK213319 · 510(k) | Viz.ai, Inc. | Radiology | QFM | database entry | |
| Deep Learning Image ReconstructionK213999 · 510(k) | GE Medical Systems, LLC. | Radiology | JAK | database entry | |
| Voluson P6, Voluson P8K213689 · 510(k) | GE Healthcare | Radiology | IYN | database entry | |
| SIGNA Artist EvoK213603 · 510(k) | GE Healthcare(Tianjin) Company Limited | Radiology | LNH | database entry | |
| RapidK213165 · 510(k) | iSchema View Inc. | Radiology | LLZ | database entry | |
| Micro C Medical Imaging System, M01K212654 · 510(k) | OXOS Medical, Inc. | Radiology | IZL | database entry | |
| Revolution AscendK213938 · 510(k) | GE Healthcare Japan Corporation | Radiology | JAK | database entry | |
| Contour ProtégéAIK213976 · 510(k) | MIM Software Inc. | Radiology | QKB | database entry | |
| syngo.CT Brain HemorrhageK203260 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | QAS | database entry | |
| Aplio i900/i800/i700 Diagnostic Ultrasound SysteK212333 · 510(k) | Canon Medical Systems Corporation | Radiology | IYN | database entry |
Every year in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.