1230 devices · 550 companies · 1998 to 2026
AI-enabled radiology devices on FDA's list
1230 devices in the Radiology panel, 1998 to 2026, from 550 companies across 40 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1186 of 1230 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes in the Radiology panel
- QIH · Automated Radiological Image Processing Software305
- LLZ · System, Image Processing, Radiological161
- IYN · System, Imaging, Pulsed Doppler, Ultrasonic124
- JAK · System, X-Ray, Tomography, Computed103
- LNH · System, Nuclear Magnetic Resonance Imaging100
- QAS · Radiological Computer-Assisted Triage And Notification Software86
- QKB · Radiological Image Processing Software For Radiation Therapy46
- MYN · Analyzer, Medical Image43
- QFM · Radiological Computer-Assisted Prioritization Software For Lesions40
- QDQ · Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer36
- MUJ · System, Planning, Radiation Therapy Treatment33
- KPS · System, Tomography, Computed, Emission26
- POK · Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer22
- OWB · Interventional Fluoroscopic X-Ray System15
- IYO · System, Imaging, Pulsed Echo, Ultrasonic12
- OEB · Lung Computed Tomography System, Computer-Aided Detection10
- QBS · Radiological Computer Assisted Detection/Diagnosis Software For Fracture10
- QJU · Image Acquisition And/Or Optimization Guided By Artificial Intelligence8
- KPR · System, X-Ray, Stationary6
- QTZ · Radiological Image Processing Software For Ablation Therapy Planning And Evaluation4
- NQQ · System, Imaging, Optical Coherence Tomography (Oct)4
- QWO · Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.4
- JAA · System, X-Ray, Fluoroscopic, Image-Intensified4
- SAO · Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density3
- IYE · Accelerator, Linear, Medical3
- MQB · Solid State X-Ray Imager (Flat Panel/Digital Imager)3
- OUO · Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance2
- OTE · Digital Breast Tomosynthesis2
- QHA · X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device2
- KGI · Densitometer, Bone2
- PCS · Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox2
- SHE · Radiological Software System For Delivery Date Prediction1
- OXO · Image-Intensified Fluoroscopic X-Ray System, Mobile1
- SGH · Ultrasound Imaging For Vascular Access For Hemodialysis1
- SEZ · Radiological Software Device To Predict Future Breast Cancer Risk1
- LDK · Device, Sensing, Optical Contour1
- QVD · Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan1
- IZL · System, X-Ray, Mobile1
- QNK · Optoacoustic Imaging System1
- NFJ · System, Image Management, Ophthalmic1
By year in the Radiology panel
Companies with more than one device here
- Siemens Medical Solutions USA, Inc.67
- Canon Medical Systems Corporation42
- Shanghai United Imaging Healthcare Co., Ltd.39
- Aidoc Medical , Ltd.35
- GE Medical Systems Ultrasound and Primary Care Diagnostics31
- Ge Medical Systems, LLC24
- Philips Ultrasound, LLC21
- Samsung Medison Co., Ltd.18
- Siemens Healthcare GmbH15
- iSchemaView, Inc.15
- GE Medical Systems SCS13
- Ever Fortune.Ai, Co., Ltd.12
- Clarius Mobile Health Corp.12
- Hyperfine, Inc.12
- Overjet, Inc.11
- Subtle Medical, Inc.10
- Coreline Soft Co.,Ltd10
- Viz.ai, Inc.10
- DiA Imaging Analysis Ltd.10
- DeepHealth, Inc.9
- Philips Medical Systems Nederland B.V.9
- Qure.Ai Technologies9
- Zebra Medical Vision Ltd.9
- Brainomix Limited8
- Ge Healthcare Japan Corporation8
- GE Healthcare8
- Pearl, Inc.8
- Quantib BV8
- Hologic, Inc.8
- RaySearch Laboratories AB (PUBL)8
- Therapixel7
- Esaote, S.p.A.7
- Mim Software, Inc.7
- BunkerHill Health7
- Circle Cardiovascular Imaging, Inc.7
- iCAD, Inc.7
- Avicenna.AI7
- Surgical Information Sciences, Inc.7
- Fujifilm Corporation6
- Lunit, Inc.6
- Terarecon,Inc.6
- Arterys, Inc.6
- ScreenPoint Medical B.V.6
- Imagen Technologies, Inc6
- Annalise-AI Pty Ltd6
- Sonio5
- Neurophet., Inc.5
- Airs Medical, Inc.5
- JLK, Inc.5
- Philips Healthcare (Suzhou) Co., Ltd.5
- Radformation, Inc.5
- Varian Medical Systems, Inc.5
- Peek Health, S.A.5
- Brightheart5
- GE Healthcare (Tianjin) Company Limited5
- Mighty Oak Medical4
- Butterfly Network, Inc.4
- Manteia Technologies Co., Ltd.4
- Therapanacea Sas4
- Eos Imaging4
- Disior Ltd4
- VideaHealth Inc.4
- Exo Inc4
- icometrix NV4
- Shanghai United Imaging Intelligence Co., Ltd.4
- EchoNous, Inc.4
- Resonance Health Analysis Services Pty Ltd4
- ClariPi Inc.4
- Caption Health4
- FUJIFILM Healthcare Americas Corporation3
- Siemens Healthineers AG3
- Imeka Solutions, Inc.3
- AZmed3
- Velmeni, Inc.3
- Smart Soft Healthcare AD3
- Perspectum, Ltd.3
- Siemens Shenzhen Magnetic Resonance , Ltd.3
- Elekta Solutions AB3
- Spectrum Dynamics Medical, Ltd.3
- Imvaria, Inc.3
- Axial Medical Printing Limited3
- Siemens Medical Solutions3
- SimBioSys, Inc.3
- Brainlab AG3
- Arineta Ltd.3
- Oncospace, Inc.3
- CureMetrix, Inc.3
- Quibim S.L.3
- Cleerly, Inc.3
- Ceevra, Inc.3
- Ventripoint Diagnostics Ltd.3
- Omega Medical Imaging, LLC3
- Ezra AI, Inc.3
- Imbio, Inc.3
- Koios Medical, Inc.3
- Limbus AI Inc.3
- CorTechs Labs, Inc.3
- iSchema View Inc.3
- Siemens Medical Solutions U.S.A.3
- MRIguidance B.V3
- TheraPanacea3
- NICo-Lab B.V.3
- Olea Medical3
- GE Medical Systems Ultrasound and3
- EXINI Diagnostics AB3
- Vysioneer Inc.3
- AmCad BioMed Corporation3
- Adas3D Medical S.L.2
- Crescom Co., Ltd.2
- Alpha Intelligence Manifolds, Inc.2
- Deski2
- OrthoGrid Systems, Inc.2
- Canon Medical Informatics, Inc.2
- Wuhan United Imaging Healthcare Co.,Ltd2
- Medicrea International S.A.S. (Medtronic)2
- Canon, Inc.2
- Quantib B.V.2
- ABBOTT MEDICAL2
- Edgecare, Inc.2
- Relu BV2
- ViTAA Medical Solutions, Inc.2
- Philips Medical Systems Technologies , Ltd.2
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2
- Beijing Infervision Healthcare Medical Technology Co., Ltd.2
- Orca Dental AI , Ltd.2
- Ligence Uab2
- Exo Imaging2
- Ai4medimaging Medical Solutions S.A.2
- DGNCT, LLC2
- Dentsply Sirona, Inc.2
- HeartLung Corporation2
- Ultrasight , Ltd.2
- Neosoma, Inc.2
- Intuitive Surgical, Inc.2
- Medcognetics, Inc.2
- Ge Hualun Medical Systems Co. , Ltd.2
- Avatar Medical2
- Thirona BV2
- Diagnoly2
- Mvision AI Oy2
- Galileo CDS, Inc2
- Methinks Software S.L.2
- Artrya Limited2
- PIUR Imaging GmbH2
- Mycardium AI Limited2
- Ewoosoft Co., Ltd2
- Infervision Medical Technology Co., Ltd.2
- Annalise-AI2
- Gleamer SAS2
- Milvue2
- Caption Health, Inc.2
- GE Medical Systems Israel, Functional Imaging2
- VinBrain Joint Stock Company2
- Riverain Technologies, Inc.2
- Ontact Health Co., Ltd2
- Vuno Inc.2
- See-Mode Technologies Pte. Ltd.2
- Sonic Incytes2
- Nano-X AI Ltd.2
- FUJIFILM Healthcare Corporation2
- Rebrain, SAS2
- AZmed SAS2
- Circle Cardiovascular Imaging2
- Heuron Co., Ltd.2
- Techsomed2
- Genesis Software Innovations2
- Eko.ai Pte. Ltd d/b/a Us2.ai2
- GE Hangwei Medical Systems Co., Ltd.2
- Quanta Computer Inc.2
- Software Nemotec S.L.2
- Nobel Biocare AB2
- Philips Ultrasound2
- BK Medical Aps2
- Medical Metrics, Inc.2
- MEDICALIP Co., Ltd2
- IB Lab GmbH2
- GE Medical Systems,LLC (GE Healthcare)2
- Gleamer2
- Aibolit Technologies, LLC2
- Therenva SAS2
- 3D-Side SA2
- GE Medical Systems2
- Elucid Bioimaging Inc.2
- GE Healthcare (GE Medical Systems, LLC)2
- Carestream Health, Inc.2
- TOMTEC Imaging Systems GmbH2
- Cydar Ltd.2
- Philips Medical Systems2
- Volpara Health Technologies Limited2
- Imbio, LLC2
- Nines, Inc.2
- Ultromics Ltd2
- MaxQ Al Ltd.2
- Philips Healthcare2
- RADLogics, Inc.2
- Densitas, Inc.2
- Bay Labs, Inc.2
- Perspectum Diagnostics Ltd2
- Body Vision Medical Ltd.2
- Medicrea International2
The newest 150 devices
1230 devices in the Radiology panel 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 | Product code | FDA |
|---|---|---|---|---|
| Auto-SegK253628 · 510(k) | Agada Medical, Ltd. | QIH | database entry | |
| ADAS 3DK253969 · 510(k) | Adas3D Medical S.L. | QIH | database entry | |
| Alturion Series Diagnostic Ultrasound SystemK260667 · 510(k) | Philips Ultrasound, LLC | IYN | database entry | |
| MammoScreenK260714 · 510(k) | Therapixel | QDQ | database entry | |
| syngo.CT Coronary CockpitK253786 · 510(k) | Siemens Medical Solutions USA, Inc. | QIH | database entry | |
| Enhanced Boundary for PCCTK253560 · 510(k) | Ge Medical Systems, LLC | JAK | database entry | |
| CMN Capillary Function with Oncology Virtual ExpK260316 · 510(k) | Cercare Medical A/S | QIH | database entry | |
| RadOncAIK253050 · 510(k) | Informai | MUJ | database entry | |
| ARTHURK260190 · 510(k) | ROPCA ApS | IYO | database entry | |
| Vascular Assist Occlusion TriageK260729 · 510(k) | GuideAI Health | QAS | database entry | |
| Synapse PACSK261713 · 510(k) | FUJIFILM Healthcare Americas Corporation | QIH | database entry | |
| ACUSON Sequoia Diagnostic Ultrasound SystemK260844 · 510(k) | Siemens Medical Solutions USA, Inc. | IYN | database entry | |
| MediAI-OAK253172 · 510(k) | Crescom Co., Ltd. | QIH | database entry | |
| LungMapsK253690 · 510(k) | Siemens Healthineers AG | QIH | database entry | |
| Saige-DxK253825 · 510(k) | DeepHealth, Inc. | QDQ | database entry | |
| WatchMate SoftwareK260300 · 510(k) | Anumana, Inc. | QIH | database entry | |
| Brainomix 360 HyperdensityK260406 · 510(k) | Brainomix Limited | QIH | database entry | |
| Acorn 3D SoftwareK260322 · 510(k) | Mighty Oak Medical | QIH | database entry | |
| DeepXray SpinaK253192 · 510(k) | Alpha Intelligence Manifolds, Inc. | SAO | database entry | |
| DEEPVESSEL PlaqueK260497 · 510(k) | Keya Medical Technology Co., Ltd. | QIH | database entry | |
| Sonio SuspectK261519 · 510(k) | Sonio | POK | database entry | |
| HeartFocusK260780 · 510(k) | Deski | QJU | database entry | |
| HistoSonics Planning ToolK252947 · 510(k) | HistoSonics, Inc. | QTZ | database entry | |
| OrthoGrid Hip AI 4.0K260077 · 510(k) | OrthoGrid Systems, Inc. | QIH | database entry | |
| ANDI 2.2K261405 · 510(k) | Imeka Solutions, Inc. | QIH | database entry | |
| Synapse Lung Nodule AIK254075 · 510(k) | Fujifilm Corporation | OEB | database entry | |
| EPIQ Series Diagnostic Ultrasound SystemK260123 · 510(k) | Philips Ultrasound, LLC | IYN | database entry | |
| EPIQ Series Diagnostic Ultrasound SystemsK260680 · 510(k) | Philips Ultrasound, LLC | IYN | database entry | |
| uMR AstraK260113 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | LNH | database entry | |
| Vitrea CT Transcatheter Aortic Valve ReplacementK260324 · 510(k) | Canon Medical Informatics, Inc. | QIH | database entry | |
| uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE VitK253720 · 510(k) | Wuhan United Imaging Healthcare Co.,Ltd | IYN | database entry | |
| BACK254131 · 510(k) | DeepHealth, Inc. | QIH | database entry | |
| MSK GoK260234 · 510(k) | Smart Alfa Teknoloji San. Ve Tic. A.S. | QIH | database entry | |
| Aquilion ONEK253596 · 510(k) | Canon Medical Systems Corporation | JAK | database entry | |
| Neurophet SCALE PETK252563 · 510(k) | Neurophet., Inc. | QIH | database entry | |
| uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUEK253716 · 510(k) | Wuhan United Imaging Healthcare Co.,Ltd | IYN | database entry | |
| SubtleHD-CTK254120 · 510(k) | Subtle Medical, Inc. | QIH | database entry | |
| Neurophet AQUAK261273 · 510(k) | Neurophet., Inc. | QIH | database entry | |
| UNiD Spine AnalyzerK261289 · 510(k) | Medicrea International S.A.S. (Medtronic) | QIH | database entry | |
| SubtleHD-PETK254013 · 510(k) | Subtle Medical, Inc. | LLZ | database entry | |
| BriefCase-TriageK261317 · 510(k) | Aidoc Medical , Ltd. | QAS | database entry | |
| MorphK260032 · 510(k) | BeauBrain Healthcare, Inc. | QIH | database entry | |
| RayvolveK260378 · 510(k) | AZmed | QBS | database entry | |
| Velmeni for DentistsK252953 · 510(k) | Velmeni, Inc. | MYN | database entry | |
| Lumify Diagnostic Ultrasound SystemK252558 · 510(k) | Philips Ultrasound, LLC | IYN | database entry | |
| MammoSightAIK252954 · 510(k) | Neurocareai, Inc. (Dba Savelife.Ai) | QFM | database entry | |
| Intelligent NRK252503 · 510(k) | Canon, Inc. | OWB | database entry | |
| Synapse 3D Base ToolsK254189 · 510(k) | Fujifilm Corporation | QIH | database entry | |
| DeepHealth ProstateAIK253682 · 510(k) | Quantib B.V. | QDQ | database entry | |
| syngo Application SoftwareK254184 · 510(k) | Siemens Medical Solutions USA, Inc. | QIH | database entry | |
| OPTIS Mobile Next Imaging SystemK253459 · 510(k) | ABBOTT MEDICAL | NQQ | database entry | |
| Lunit INSIGHT MMGK260320 · 510(k) | Lunit, Inc. | QDQ | database entry | |
| DS Core CBCT AnatomyK260785 · 510(k) | Dentsply Sirona | QIH | database entry | |
| uOmnispace.MRK253077 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | QIH | database entry | |
| EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEMK253163 · 510(k) | Ever Fortune.Ai, Co., Ltd. | QAS | database entry | |
| FolliscanK252332 · 510(k) | Mim Fertility | QIH | database entry | |
| EdgeFlow UW20K252237 · 510(k) | Edgecare, Inc. | IYO | database entry | |
| Critical Care Suite with Enteric Tube PositioninK253502 · 510(k) | Ge Medical Systems, LLC | QIH | database entry | |
| DeepBT Detector-PlusK252190 · 510(k) | Aitewan Biomedical Technology, Inc. | QKB | database entry | |
| AI-Rad Companion Organs RTK252548 · 510(k) | Siemens Healthcare GmbH | QKB | database entry | |
| Relu CloudK252708 · 510(k) | Relu BV | QIH | database entry | |
| syngo DynamicsK253689 · 510(k) | Siemens Healthcare GmbH | QIH | database entry | |
| Overjet Iris Intelligent Imaging SystemK253930 · 510(k) | Overjet, Inc. | QIH | database entry | |
| 6450 Ultrasound SystemK253288 · 510(k) | Esaote, S.p.A. | IYN | database entry | |
| uMI PanvivoK260524 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | KPS | database entry | |
| CoLumbo C-SpineK254015 · 510(k) | Smart Soft Healthcare AD | QIH | database entry | |
| AiORTA - Plan v2.0K254207 · 510(k) | ViTAA Medical Solutions, Inc. | QIH | database entry | |
| Spectral CT Verida FamilyK253649 · 510(k) | Philips Medical Systems Technologies , Ltd. | JAK | database entry | |
| Butterfly Gestational Age ToolK252148 · 510(k) | Butterfly Network, Inc. | IYN | database entry | |
| Automated Aortic Stenosis SoftwareK254161 · 510(k) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | POK | database entry | |
| EPIQ Series Diagnostic Ultrasound System, AffiniK253595 · 510(k) | Philips Ultrasound, LLC | IYN | database entry | |
| Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 withK253625 · 510(k) | Canon Medical Systems Corporation | LNH | database entry | |
| S-scan OpenK260746 · 510(k) | Esaote, S.p.A. | LNH | database entry | |
| Contour ProtégéAI+K253270 · 510(k) | Mim Software, Inc. | QKB | database entry | |
| Lunit INSIGHT DBTK253796 · 510(k) | Lunit, Inc. | QDQ | database entry | |
| SwiftMRK253775 · 510(k) | Airs Medical, Inc. | QIH | database entry | |
| TriniasK252099 · 510(k) | Shimadzu Corporation | OWB | database entry | |
| JLK-NCCTK252421 · 510(k) | JLK, Inc. | QAS | database entry | |
| LOGIQ VitaK260673 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | database entry | |
| CT Rembra RTK252992 · 510(k) | Philips Healthcare (Suzhou) Co., Ltd. | JAK | database entry | |
| True Definition DLK253686 · 510(k) | Ge Healthcare Japan Corporation | JAK | database entry | |
| Photonova Spectra, Photonova Spectra SelectK253520 · 510(k) | Ge Medical Systems, LLC | JAK | database entry | |
| SOMATOM X.citeK253574 · 510(k) | Siemens Medical Solutions USA, Inc. | JAK | database entry | |
| AutoContourK260509 · 510(k) | Radformation, Inc. | QKB | database entry | |
| syngo.via RT Image Suite VC10K252304 · 510(k) | Varian Medical Systems, Inc. | MUJ | database entry | |
| EchoNavigator R5.0K253614 · 510(k) | Philips Medical Systems Nederland B.V. | QIH | database entry | |
| Data Analysis Facilitation SuiteK253944 · 510(k) | Voronoi Health Analytics Incorporated | QIH | database entry | |
| Sonio DetectK252433 · 510(k) | Sonio | IYN | database entry | |
| InferCare RECISTK252261 · 510(k) | Beijing Infervision Healthcare Medical Technology Co., Ltd. | QIH | database entry | |
| Aquilion ServeSPK260078 · 510(k) | Canon Medical Systems Corporation | JAK | database entry | |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 withK253584 · 510(k) | Canon Medical Systems Corporation | OWB | database entry | |
| LiverMultiScanK253413 · 510(k) | Perspectum, Ltd. | LNH | database entry | |
| Bunkerhill Contrast CACK260166 · 510(k) | BunkerHill Health | JAK | database entry | |
| Bunkerhill Contrast AVCK260167 · 510(k) | BunkerHill Health | JAK | database entry | |
| VELYS Hip NavigationK253551 · 510(k) | Depuy Ireland UC | QIH | database entry | |
| CEPHX3DK252538 · 510(k) | Orca Dental AI , Ltd. | QIH | database entry | |
| AV Cardiac CTK260169 · 510(k) | Philips Medical Systems Nederland B.V. | JAK | database entry | |
| Magnifico OpenK251901 · 510(k) | Esaote, S.p.A. | LNH | database entry | |
| QT Scanner 2000 Model AK253898 · 510(k) | QT Imaging Holdings, Inc. | IYO | database entry | |
| Annalise EnterpriseK253818 · 510(k) | Harrison-AI Medical Pty, Ltd. | QAS | database entry | |
| Clarius Ejection Fraction AIK253593 · 510(k) | Clarius Mobile Health Corp. | QIH | database entry | |
| Ligence HeartK253535 · 510(k) | Ligence Uab | QIH | database entry | |
| BriefCase-Triage: CARE Multi-Triage CT for PneumK253578 · 510(k) | Aidoc Medical , Ltd. | QAS | database entry | |
| AI Platform 2.2K260217 · 510(k) | Exo Imaging | QIH | database entry | |
| Ingenia, Ingenia CX, Ingenia Elition S/X, IngeniK253648 · 510(k) | Philips Medical Systems Nederland B.V. | LNH | database entry | |
| MAGNETOM Flow.AceK260265 · 510(k) | Siemens Shenzhen Magnetic Resonance , Ltd. | LNH | database entry | |
| CARA SystemK252500 · 510(k) | Cara Medical, Ltd. | OWB | database entry | |
| Monaco RTP SystemK252002 · 510(k) | Elekta Solutions AB | MUJ | database entry | |
| uMI PanvivoK253564 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | KPS | database entry | |
| Delivery Date AIDEN250007 · De Novo | Ultrasound AI | SHE | database entry | |
| AI4CMR v2.0K252084 · 510(k) | Ai4medimaging Medical Solutions S.A. | QIH | database entry | |
| MI View&GOK254016 · 510(k) | Siemens Medical Solutions USA, Inc. | QIH | database entry | |
| Median LCSK251474 · 510(k) | Median Technologies | QDQ | database entry | |
| SIGNA BoltK253780 · 510(k) | Ge Medical Systems, LLC | LNH | database entry | |
| SIGNA Sprint SelectK253779 · 510(k) | Ge Medical Systems, LLC | LNH | database entry | |
| RevealAI-LungK251769 · 510(k) | Precision Medical Ventures, Inc. Dba Revealdx | POK | database entry | |
| Surgical Reality ViewerK252091 · 510(k) | Medicalvr B.V. | QIH | database entry | |
| Neurophet AQUA AD PlusK252496 · 510(k) | Neurophet., Inc. | QIH | database entry | |
| Seg Pro V3K251306 · 510(k) | Ever Fortune.Ai, Co., Ltd. | QKB | database entry | |
| BriefCase-TriageK251195 · 510(k) | Aidoc Medical , Ltd. | QAS | database entry | |
| AccuContour 4.0K251351 · 510(k) | Manteia Technologies Co., Ltd. | QKB | database entry | |
| AV VascularK253735 · 510(k) | Philips Medical Systems Nederland B.V. | QIH | database entry | |
| AI-Rad Companion Brain MRK253057 · 510(k) | Siemens Healthcare GmbH | QIH | database entry | |
| uCT 780 with uWS-CT-Dual Energy AnalysisK253173 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | JAK | database entry | |
| qXR-DetectK251934 · 510(k) | Qure.Ai Technologies | MYN | database entry | |
| Imagine Enterprise SuiteK252634 · 510(k) | Softlink International Private Limited | QIH | database entry | |
| DiagnocatK252934 · 510(k) | DGNCT, LLC | MYN | database entry | |
| BIOGRAPH OneK253023 · 510(k) | Siemens Healthineers AG | OUO | database entry | |
| EMLAK252188 · 510(k) | Elekta Solutions AB | IYE | database entry | |
| VERITON CT 300 Series Digital SPECT/CT SystemK254001 · 510(k) | Spectrum Dynamics Medical, Ltd. | KPS | database entry | |
| LOGIQ TotusK253370 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | database entry | |
| DS Core DetectK253009 · 510(k) | Dentsply Sirona, Inc. | MYN | database entry | |
| BriefCase-Triage: CARE Multi-triage CT BodyK252970 · 510(k) | Aidoc Medical , Ltd. | QAS | database entry | |
| LOGIQ FortisK253366 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | database entry | |
| HERA Z20 Diagnostic Ultrasound SystemK252018 · 510(k) | Samsung Medison Co., Ltd. | IYN | database entry | |
| TruSPECT Processing StationK253532 · 510(k) | Spectrum Dynamics Medical, Ltd. | QIH | database entry | |
| AIR Recon DLK252379 · 510(k) | Ge Medical Systems, LLC | LNH | database entry | |
| ART-Plan+K253091 · 510(k) | Therapanacea Sas | MUJ | database entry | |
| PeekMed webK252856 · 510(k) | Peek Health, S.A. | QIH | database entry | |
| BioticsAIK250959 · 510(k) | Bioticsai, Inc. | IYN | database entry | |
| Lumify Diagnostic Ultrasound SystemK252557 · 510(k) | Philips Ultrasound, LLC | IYN | database entry | |
| AlzevitaK252670 · 510(k) | TOPIA MEDTECH LIMITED | QIH | database entry | |
| MAGNETOM SolaK252838 · 510(k) | Siemens Healthcare GmbH | LNH | database entry | |
| AI-CVDK252029 · 510(k) | HeartLung Corporation | QIH | database entry | |
| MediAI-BAK250914 · 510(k) | Crescom Co., Ltd. | QIH | database entry | |
| PVAD IQ SoftwareK252235 · 510(k) | Ultrasight , Ltd. | QIH | database entry | |
| UltraSight GuidanceK251416 · 510(k) | Ultrasight , Ltd. | QJU | database entry | |
| Neosoma Brain MetsK252922 · 510(k) | Neosoma, Inc. | QIH | database entry | |
| IRISegK251763 · 510(k) | Intuitive Surgical, Inc. | QIH | database entry | |
| Swoop Portable MR Imaging SystemK253489 · 510(k) | Hyperfine, Inc. | LNH | database entry |
Every panel in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.