335 devices · 247 companies · 2025
AI-enabled medical devices FDA authorized in 2025
335 devices authorized in 2025, 2025, from 247 companies across 80 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (329 of 335 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes authorized in 2025
- QIH · Automated Radiological Image Processing Software93
- IYN · System, Imaging, Pulsed Doppler, Ultrasonic29
- LNH · System, Nuclear Magnetic Resonance Imaging23
- QAS · Radiological Computer-Assisted Triage And Notification Software15
- MYN · Analyzer, Medical Image14
- JAK · System, X-Ray, Tomography, Computed13
- LLZ · System, Image Processing, Radiological11
- MUJ · System, Planning, Radiation Therapy Treatment6
- DQK · Computer, Diagnostic, Programmable6
- QKB · Radiological Image Processing Software For Radiation Therapy6
- QNP · Gastrointesinal Lesion Software Detection System5
- POK · Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer5
- OWB · Interventional Fluoroscopic X-Ray System5
- QDQ · Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer5
- MNR · Ventilatory Effort Recorder4
- SBF · Orthopedic Augmented Reality4
- OLO · Orthopedic Stereotaxic Instrument4
- DQD · Stethoscope, Electronic3
- QJU · Image Acquisition And/Or Optimization Guided By Artificial Intelligence3
- QFM · Radiological Computer-Assisted Prioritization Software For Lesions3
- OEB · Lung Computed Tomography System, Computer-Aided Detection3
- KPS · System, Tomography, Computed, Emission3
- KPR · System, X-Ray, Stationary3
- QYE · Reduced Ejection Fraction Machine Learning-Based Notification Software3
- MXD · Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)2
- POS · Physiological Signal Based Seizure Monitoring System2
- OLZ · Automatic Event Detection Software For Polysomnograph With Electroencephalograph2
- QWO · Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.2
- LWS · Implantable Cardioverter Defibrillator (Non-Crt)2
- QHA · X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device2
- QZB · Software Controlled Endoscope And Instrument Holder2
- SDJ · Adjunctive Cardiac Amyloidosis Status Indicator2
- POV · Semen Analysis Device2
- QPF · Pediatric Autism Spectrum Disorder Diagnosis Aid2
- PPW · Adjunctive Cardiovascular Status Indicator1
- QKQ · Digital Pathology Image Viewing And Management Software1
- NCG · Neuropsychiatric Interpretative Electroencephalograph Assessment Aid1
- BZD · Ventilator, Non-Continuous (Respirator)1
- MYE · System, Electrogastrography (Egg)1
- OXO · Image-Intensified Fluoroscopic X-Ray System, Mobile1
- QQI · Interventional Cardiovascular Implant Simulation Software Device1
- QUO · Adjunctive Heart Failure Status Indicator1
- OTE · Digital Breast Tomosynthesis1
- SGH · Ultrasound Imaging For Vascular Access For Hemodialysis1
- PZP · Fluid Jet Removal System1
- SFR · Hypertension Machine Learning-Based Notification Software1
- QTZ · Radiological Image Processing Software For Ablation Therapy Planning And Evaluation1
- SAO · Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density1
- PZM · Next Generation Sequencing Based Tumor Profiling Test1
- QME · Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate1
- QRG · Ultrasound Guided Nerve Block Assist1
- PBH · Embryo Image Assessment System, Assisted Reproduction1
- DPS · Electrocardiograph1
- SFH · Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis1
- PJA · Coronary Vascular Physiologic Simulation Software1
- QBC · External Upper Limb Tremor Stimulator1
- JOY · Device, Automated Cell-Locating1
- SFE · Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation1
- QDA · Electrocardiograph Software For Over-The-Counter Use1
- MWI · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1
- SEZ · Radiological Software Device To Predict Future Breast Cancer Risk1
- IYO · System, Imaging, Pulsed Echo, Ultrasonic1
- DSH · Recorder, Magnetic Tape, Medical1
- MVK · Wearable Automated External Defibrillator1
- QER · Camera, Ophthalmic, Slit-Scanning1
- OMB · Automatic Event Detection Software For Full-Montage Electroencephalograph1
- KGI · Densitometer, Bone1
- PHZ · Abnormal Breath Sound Device1
- MAX · Intervertebral Fusion Device With Bone Graft, Lumbar1
- BZQ · Monitor, Breathing Frequency1
- SDY · Loss Of Pulse Notification Software1
- OLV · Standard Polysomnograph With Electroencephalograph1
- KWS · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1
- HAW · Neurological Stereotaxic Instrument1
- QPN · Software Algorithm Device To Assist Users In Digital Pathology1
- QHE · Shoulder Arthroplasty Implantation System1
- QBS · Radiological Computer Assisted Detection/Diagnosis Software For Fracture1
- HGM · System, Monitoring, Perinatal1
- PRE · Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers1
- JAA · System, X-Ray, Fluoroscopic, Image-Intensified1
Panels
Companies with more than one device here
- Shanghai United Imaging Healthcare Co., Ltd.12
- Ge Medical Systems Ultrasound and Primary Care Diagnostics10
- Philips Ultrasound, LLC9
- Pearl, Inc.7
- Canon Medical Systems Corporation6
- Ge Medical Systems, LLC5
- Siemens Healthcare GmbH5
- Bunkerhill Health5
- Peek Health, S.A.4
- Brightheart4
- iSchemaView, Inc.4
- Siemens Medical Solutions USA, Inc.4
- Hyperfine, Inc.3
- Huxley Medical3
- Coreline Soft Co.,Ltd3
- Esaote, S.P.A.3
- Aidoc Medical , Ltd.3
- Fujifilm Corporation3
- Brainomix Limited3
- GE Medical Systems SCS3
- DiA Imaging Analysis Ltd.3
- Therapanacea Sas2
- Iterative Health2
- Ultrasight , Ltd.2
- Medicalgorithmics S.A.2
- Mighty Oak Medical2
- Ge Hualun Medical Systems Co. , Ltd.2
- GE Healthcare2
- Siemens Shenzhen Magnetic Resonance , Ltd.2
- Nox Medical Ehf2
- Eos Imaging2
- Imvaria, Inc.2
- Circle Cardiovascular Imaging, Inc.2
- Terarecon,Inc.2
- Avatar Medical2
- Magentiq Eye, Ltd.2
- Augmedics, Ltd.2
- Volta Medical2
- Galileo CDS, Inc2
- Therapixel2
- Methinks Software S.L.2
- Artrya Limited2
- Siemens Medical Solutions2
- Samsung Medison Co., Ltd.2
- Moon Surgical2
- THINK Surgical, Inc.2
- Brainlab AG2
- Bonraybio Co., LTD.2
- Clarius Mobile Health Corp.2
- Arineta Ltd.2
- AZmed2
- JLK, Inc.2
- Gleamer SAS2
The newest 150 devices
335 devices authorized in 2025 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 |
|---|---|---|---|---|---|
| TruSPECT Processing StationK253532 · 510(k) | Spectrum Dynamics Medical, Ltd. | Radiology | QIH | database entry | |
| AIR Recon DLK252379 · 510(k) | Ge Medical Systems, LLC | Radiology | LNH | database entry | |
| ART-Plan+K253091 · 510(k) | Therapanacea Sas | Radiology | MUJ | database entry | |
| PeekMed webK252856 · 510(k) | Peek Health, S.A. | Radiology | QIH | database entry | |
| SKOUT systemK253664 · 510(k) | Iterative Health | Gastroenterology-Urology | QNP | database entry | |
| BioticsAIK250959 · 510(k) | Bioticsai, Inc. | Radiology | IYN | database entry | |
| Lumify Diagnostic Ultrasound SystemK252557 · 510(k) | Philips Ultrasound, LLC | Radiology | IYN | database entry | |
| AlzevitaK252670 · 510(k) | TOPIA MEDTECH LIMITED | Radiology | QIH | database entry | |
| eMurmur Heart AIK252284 · 510(k) | Csd Labs | Cardiovascular | DQD | database entry | |
| MAGNETOM SolaK252838 · 510(k) | Siemens Healthcare GmbH | Radiology | LNH | database entry | |
| AI-CVDK252029 · 510(k) | HeartLung Corporation | Radiology | QIH | database entry | |
| MediAI-BAK250914 · 510(k) | Crescom Co., Ltd. | Radiology | QIH | database entry | |
| Assert-IQK253516 · 510(k) | Abbott Medical | Cardiovascular | MXD | database entry | |
| PVAD IQ SoftwareK252235 · 510(k) | Ultrasight , Ltd. | Radiology | QIH | database entry | |
| UltraSight GuidanceK251416 · 510(k) | Ultrasight , Ltd. | Radiology | QJU | database entry | |
| Neosoma Brain MetsK252922 · 510(k) | Neosoma, Inc. | Radiology | QIH | database entry | |
| IRISegK251763 · 510(k) | Intuitive Surgical, Inc. | Radiology | QIH | database entry | |
| prolaio eVO2peak ModuleK252204 · 510(k) | Prolaio, Inc. | Cardiovascular | PPW | database entry | |
| Swoop Portable MR Imaging SystemK253489 · 510(k) | Hyperfine, Inc. | Radiology | LNH | database entry | |
| CogNet AI-MT+K252482 · 510(k) | Medcognetics, Inc. | Radiology | QFM | database entry | |
| DeepRhythmAIK253141 · 510(k) | Medicalgorithmics S.A. | Cardiovascular | DQK | database entry | |
| SANSA HSATK252497 · 510(k) | Huxley Medical | Anesthesiology | MNR | database entry | |
| INFINITT DPSK243449 · 510(k) | Infinitt Healthcare Co., Ltd. | Pathology | QKQ | database entry | |
| Fetal EchoScanK252294 · 510(k) | Brightheart | Radiology | POK | database entry | |
| Ceribell Delirium Monitor SystemK251936 · 510(k) | Ceribell, Inc. | Neurology | NCG | database entry | |
| Personalized Therapy Comfort SettingsK251657 · 510(k) | ResMed Corp | Anesthesiology | BZD | database entry | |
| ARTAssistantK250780 · 510(k) | Manteia Technologies Co., Ltd. | Radiology | QKB | database entry | |
| Overjet CBCT AssistK251514 · 510(k) | Overjet, Inc. | Radiology | QIH | database entry | |
| Gastric AlimetryK252504 · 510(k) | Alimetry , Ltd. | Gastroenterology-Urology | MYE | database entry | |
| AVIEW Lung Nodule CADK251203 · 510(k) | Coreline Soft Co.,Ltd | Radiology | OEB | database entry | |
| Acorn 3D SoftwareK252103 · 510(k) | Mighty Oak Medical | Radiology | QIH | database entry | |
| Cartesion PrimeK251370 · 510(k) | Canon Medical Systems Corporation | Radiology | KPS | database entry | |
| CT VScore+K252217 · 510(k) | Canon Medical Informatics, Inc. | Radiology | JAK | database entry | |
| OEC One CFDK253269 · 510(k) | Ge Hualun Medical Systems Co. , Ltd. | Radiology | OXO | database entry | |
| Scaida BrainCT-ICHK250694 · 510(k) | Mlhealth 360 | Radiology | QAS | database entry | |
| 7600 Ultrasound SystemK253310 · 510(k) | Esaote, S.P.A. | Radiology | IYN | database entry | |
| FEops HEARTguide Simulation ApplicationK250635 · 510(k) | Feops NV | Cardiovascular | QQI | database entry | |
| Voluson Expert 18K252328 · 510(k) | Ge Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN | database entry | |
| a2z-Unified-TriageK252366 · 510(k) | A2z Radiology Ai, Inc. | Radiology | QAS | database entry | |
| CardioVisionK251293 · 510(k) | Icardio.Ai | Cardiovascular | QUO | database entry | |
| NelliK251506 · 510(k) | Neuro Event Labs OY | Neurology | POS | database entry | |
| Senographe Pristina 3DP130020/S005 · PMA | GE Healthcare | Radiology | OTE | database entry | |
| MAGNETOM Free.MaxK251822 · 510(k) | Siemens Shenzhen Magnetic Resonance , Ltd. | Radiology | LNH | database entry | |
| DTX Studio AssistK252086 · 510(k) | Nobel Biocare C/O Medicim NV | Radiology | MYN | database entry | |
| DeepRESPK252330 · 510(k) | Nox Medical Ehf | Neurology | OLZ | database entry | |
| Second Opinion PanoramicK250525 · 510(k) | Pearl, Inc. | Radiology | MYN | database entry | |
| AutoDensityK251078 · 510(k) | Eos Imaging | Radiology | QIH | database entry | |
| PeekMed webK252452 · 510(k) | Peek Health, S.A. | Radiology | QIH | database entry | |
| SugarBugK250264 · 510(k) | Bench7, Inc. | Radiology | MYN | database entry | |
| FibresolveK252041 · 510(k) | Imvaria, Inc. | Radiology | QWO | database entry | |
| BriefCase-TriageK253265 · 510(k) | Aidoc Medical , Ltd. | Radiology | QAS | database entry | |
| 3mensio WorkstationK250330 · 510(k) | Pie Medical Imaging BV | Radiology | QIH | database entry | |
| Acorn 3D SoftwareK251532 · 510(k) | Mighty Oak Medical | Radiology | LLZ | database entry | |
| Aplio i900, Aplio i800 and Aplio i700 Software VK252074 · 510(k) | Canon Medical Systems Corporation | Radiology | IYN | database entry | |
| AiORTA - PlanK250337 · 510(k) | ViTAA Medical Solutions, Inc. | Radiology | QIH | database entry | |
| LOGIQ E10K251985 · 510(k) | Ge Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN | database entry | |
| LOGIQ E10sK251963 · 510(k) | Ge Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN | database entry | |
| SANSA HSATK250882 · 510(k) | Huxley Medical | Anesthesiology | MNR | database entry | |
| Aurora EV ICDP220012/S059 · PMA | Medtronic, Inc. | Cardiovascular | LWS | database entry | |
| Cobalt MRI ICDP980016/S939 · PMA | Medtronic Cardiac Rhythm Disease Management | Cardiovascular | LWS | database entry | |
| cvi42 Coronary Plaque Software ApplicationK251027 · 510(k) | Circle Cardiovascular Imaging, Inc. | Radiology | QIH | database entry | |
| Syngo Carbon ClinicalsK251059 · 510(k) | Siemens Healthineers AG | Radiology | QIH | database entry | |
| TeraRecon Cardiovascular.Calcification.CTK250288 · 510(k) | Terarecon,Inc. | Radiology | QIH | database entry | |
| ANDI 2.0K252298 · 510(k) | Imeka Solutions, Inc. | Radiology | QIH | database entry | |
| brAIn Shoulder PositioningK252665 · 510(k) | Avatar Medical | Radiology | QIH | database entry | |
| X9 Ultrasound SystemK251673 · 510(k) | X9, Inc. | Radiology | SGH | database entry | |
| X1-FFRK251355 · 510(k) | Spectrawave, Inc. | Radiology | QHA | database entry | |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 withK251602 · 510(k) | Canon Medical Systems Corporation | Radiology | OWB | database entry | |
| HYDROS Robotic SystemK251082 · 510(k) | Procept Biorobotics | General and Plastic Surgery | PZP | database entry | |
| EPIQ Series Diagnostic Ultrasound SystemK251651 · 510(k) | Philips Ultrasound, LLC | Radiology | IYN | database entry | |
| AIAS CephalonK252214 · 510(k) | Metamorphosis GmbH | Radiology | QIH | database entry | |
| BlineSlideK252007 · 510(k) | Deep Breathe, Inc. | Radiology | QIH | database entry | |
| Bunkerhill MACK250662 · 510(k) | Bunkerhill Health | Radiology | JAK | database entry | |
| MAGENTIQ-COLOK252178 · 510(k) | Magentiq Eye, Ltd. | Gastroenterology-Urology | QNP | database entry | |
| xvision Spine systemK251639 · 510(k) | Augmedics, Ltd. | Neurology | SBF | database entry | |
| LungQ 4K250766 · 510(k) | Thirona BV | Radiology | JAK | database entry | |
| SMART PCFDK250023 · 510(k) | Disior Ltd | Radiology | QIH | database entry | |
| SpineAR SNAPK252054 · 510(k) | Surgical Theater, Inc. | Neurology | SBF | database entry | |
| Ligence HeartK252105 · 510(k) | Ligence, UAB | Radiology | QIH | database entry | |
| uMR 680K252371 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | LNH | database entry | |
| Brain WMHK251527 · 510(k) | Quantib BV | Radiology | QIH | database entry | |
| SwiftSight-BrainK251483 · 510(k) | AIRS Medical Inc. | Radiology | QIH | database entry | |
| Rapid Aortic MeasurementsK251987 · 510(k) | iSchemaView, Inc. | Radiology | QIH | database entry | |
| uDR Aurora CXK251167 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | KPR | database entry | |
| Videa Dental AIK251002 · 510(k) | VideaHealth Inc. | Radiology | MYN | database entry | |
| Bunkerhill ECG-EFK250649 · 510(k) | BunkerHill Health | Cardiovascular | QYE | database entry | |
| Axial3D InsightK250369 · 510(k) | Axial Medical Printing Limited | Radiology | QIH | database entry | |
| ECHELON SynergyK251386 · 510(k) | Fujifilm Corporation | Radiology | LNH | database entry | |
| Assert-IQK251221 · 510(k) | Abbott | Cardiovascular | MXD | database entry | |
| InferOperate SuiteK250237 · 510(k) | Beijing Infervision Healthcare Medical Technology Co., Ltd. | Radiology | QIH | database entry | |
| CADDIEK252586 · 510(k) | Odin Medical Limited | Gastroenterology-Urology | QNP | database entry | |
| Volta AF-Xplorer IIK251518 · 510(k) | Volta Medical | Cardiovascular | DQK | database entry | |
| FETOLYK251368 · 510(k) | Diagnoly | Radiology | IYN | database entry | |
| Stethophone ProK252595 · 510(k) | Sparrow Acoustics, Inc. | Cardiovascular | DQD | database entry | |
| SIGNA SprintK251399 · 510(k) | GE Medical Systems, LLC | Radiology | LNH | database entry | |
| Hypertension Notification FeatureK250507 · 510(k) | Apple Inc. | Cardiovascular | SFR | database entry | |
| Mazor X System / Mazor X Stealth EditionK251316 · 510(k) | Mazor Robotics Ltd. | Neurology | OLO | database entry | |
| AngioWaveNetK244002 · 510(k) | Angiowave Imaging, Inc. | Radiology | QIH | database entry | |
| Segmentron ViewerK251072 · 510(k) | DGNCT, LLC | Radiology | QIH | database entry | |
| MuscleView 2.0K251682 · 510(k) | Springbok, Inc. (dba Springbok Analytics) | Radiology | LNH | database entry | |
| BioTraceIO VisionK251931 · 510(k) | Techsomed Medical Technologies | Radiology | QTZ | database entry | |
| qER-CTAK251610 · 510(k) | Qure.ai Technologies | Radiology | QAS | database entry | |
| Rapid Obstructive Hydrocephalus, Rapid OHK251533 · 510(k) | iSchemaView Inc. | Radiology | QAS | database entry | |
| Dose+K250064 · 510(k) | Mvision AI Oy | Radiology | MUJ | database entry | |
| Careverse CoronaryDocK251656 · 510(k) | Careverse Technology Pte. Ltd. | Radiology | QIH | database entry | |
| Tempus PixelK252539 · 510(k) | Arterys, Inc. | Radiology | QIH | database entry | |
| OsteoSight HipK251408 · 510(k) | Naitive Technologies Ltd | Radiology | SAO | database entry | |
| VELMENI for DENTISTSK250753 · 510(k) | Velmeni Inc. | Radiology | MYN | database entry | |
| Sonosite LX and Sonosite PX Ultrasound SystemsK251106 · 510(k) | Fujifilm Sonosite Inc | Radiology | IYN | database entry | |
| GENESEEQPRIME NGS Tumor Profiling AssayK250003 · 510(k) | Geneseeq Technology Inc. | Pathology | PZM | database entry | |
| SurgiTwinK250290 · 510(k) | Twinsight | Radiology | LLZ | database entry | |
| PRAEVAorta2K243859 · 510(k) | Nurea | Radiology | QIH | database entry | |
| Definium Tempo SelectK250788 · 510(k) | GE Hualun Medical Systems Co., Ltd | Radiology | KPR | database entry | |
| Vital SignsK243687 · 510(k) | Oxehealth Limited | Cardiovascular | QME | database entry | |
| Brainomix 360 Triage StrokeK251983 · 510(k) | Brainomix Limited | Radiology | QAS | database entry | |
| GBrain MRIK252362 · 510(k) | Galileo CDS, Inc | Radiology | QIH | database entry | |
| MammoScreen BDK243685 · 510(k) | Therapixel | Radiology | QIH | database entry | |
| Vista OS, Vista AI Scan, RTHawkK251029 · 510(k) | Vista AI, Inc. | Radiology | LNH | database entry | |
| Methinks CTA StrokeK251590 · 510(k) | Methinks Software S.L. | Radiology | QAS | database entry | |
| Salix Coronary PlaqueK251837 · 510(k) | Artrya Limited | Radiology | QIH | database entry | |
| ACUSON Sequoia Diagnostic Ultrasound SystemK251481 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | IYN | database entry | |
| VEA AlignK251747 · 510(k) | EOS imaging | Radiology | QIH | database entry | |
| NervebloxK250818 · 510(k) | Smart Alfa Teknoloji San. Ve Tic. A.S. | Anesthesiology | QRG | database entry | |
| CHLOE BLASTK243851 · 510(k) | Fairtility Ltd. | Obstetrics and Gynecology | PBH | database entry | |
| DS Core DiagnosisK250755 · 510(k) | Dentsply Sirona Inc. | Radiology | QIH | database entry | |
| Eko Foundation Analysis Software with TransformeK251494 · 510(k) | Eko Health, Inc. | Cardiovascular | DQD | database entry | |
| Saige-DxK251873 · 510(k) | DeepHealth, Inc. | Radiology | QDQ | database entry | |
| UNiD Spine AnalyzerK251629 · 510(k) | Medicrea International S.A.S. (Medtronic) | Radiology | QIH | database entry | |
| Cardiologs Holter PlatformK250569 · 510(k) | Philips France Commercial | Cardiovascular | DPS | database entry | |
| uMR JupiterK250246 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | LNH | database entry | |
| Revolution VibeK250941 · 510(k) | GE Medical Systems, LLC | Radiology | JAK | database entry | |
| Genius AI Detection 2.0K243341 · 510(k) | Hologic, Inc. | Radiology | QDQ | database entry | |
| YSIO X.preeK250738 · 510(k) | Siemens Medical Solutions | Radiology | KPR | database entry | |
| ArteraAI ProstateDEN240068 · De Novo | Artera Inc. | Pathology | SFH | database entry | |
| Voxel DosimetryK243919 · 510(k) | Hermes Medical Solutions AB | Radiology | QIH | database entry | |
| ECG-AI Low Ejection FractionK250652 · 510(k) | Anumana, Inc. | Cardiovascular | QYE | database entry | |
| VenueK251322 · 510(k) | GE Medical Systems Ultrasound and Primary care Diagnostics, | Radiology | IYN | database entry | |
| EPIQ Series Diagnostic Ultrasound SystemK251455 · 510(k) | Philips Ultrasound LLC | Radiology | IYN | database entry | |
| Neuro Insight V1.0K243681 · 510(k) | Olea Medical S.A.S. | Radiology | LLZ | database entry | |
| Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 withK250901 · 510(k) | Canon Medical Systems Corporation | Radiology | LNH | database entry | |
| GyriCalcK250686 · 510(k) | NeuroSpectrum Insights Corp. | Radiology | LLZ | database entry | |
| HeartFlow AnalysisK250902 · 510(k) | HeartFlow, Inc. | Cardiovascular | PJA | database entry | |
| V8 Diagnostic Ultrasound SystemK250999 · 510(k) | Samsung Medison Co., Ltd. | Radiology | IYN | database entry | |
| uMR UltraK243547 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | LNH | database entry | |
| uMI PanvivoK251839 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | KPS | database entry | |
| uMR 680K243397 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | LNH | database entry | |
| Rapid CTA 360K251151 · 510(k) | iSchemaView | Radiology | QAS | database entry | |
| EchoPAC Software Only / EchoPAC Plug-inK251342 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | QIH | database entry | |
| Tempus ECG-Low EFK250119 · 510(k) | Tempus AI, Inc. | Cardiovascular | QYE | database entry | |
| PeekMed webK251096 · 510(k) | Peek Health, S.A. | Radiology | QIH | database entry |
Every year in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.