181 devices · 132 companies · 2026
AI-enabled medical devices FDA authorized in 2026
181 devices authorized in 2026, 2026, from 132 companies across 63 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (177 of 181 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes authorized in 2026
- QIH · Automated Radiological Image Processing Software48
- IYN · System, Imaging, Pulsed Doppler, Ultrasonic15
- JAK · System, X-Ray, Tomography, Computed12
- LNH · System, Nuclear Magnetic Resonance Imaging9
- QAS · Radiological Computer-Assisted Triage And Notification Software8
- QDQ · Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer6
- QKB · Radiological Image Processing Software For Radiation Therapy6
- MYN · Analyzer, Medical Image4
- OWB · Interventional Fluoroscopic X-Ray System4
- MUJ · System, Planning, Radiation Therapy Treatment3
- IYO · System, Imaging, Pulsed Echo, Ultrasonic3
- POK · Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer3
- DQK · Computer, Diagnostic, Programmable3
- KPS · System, Tomography, Computed, Emission3
- OLZ · Automatic Event Detection Software For Polysomnograph With Electroencephalograph2
- MNR · Ventilatory Effort Recorder2
- QNP · Gastrointesinal Lesion Software Detection System2
- DQD · Stethoscope, Electronic2
- QHE · Shoulder Arthroplasty Implantation System2
- SAO · Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density1
- QXO · Cardiovascular Machine Learning-Based Notification Software1
- SFE · Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation1
- SIG · Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)1
- QJU · Image Acquisition And/Or Optimization Guided By Artificial Intelligence1
- PHZ · Abnormal Breath Sound Device1
- QTZ · Radiological Image Processing Software For Ablation Therapy Planning And Evaluation1
- OEB · Lung Computed Tomography System, Computer-Aided Detection1
- SIF · Software Device System For Estimation Of Cardiac Pressures1
- SHY · Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.1
- PBH · Embryo Image Assessment System, Assisted Reproduction1
- LLZ · System, Image Processing, Radiological1
- QBS · Radiological Computer Assisted Detection/Diagnosis Software For Fracture1
- PNN · Orthodontic Software1
- PHX · Shoulder Prosthesis, Reverse Configuration1
- QFM · Radiological Computer-Assisted Prioritization Software For Lesions1
- SHW · Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis1
- CCK · Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase1
- SAK · Software Device To Aid In The Prediction Or Diagnosis Of Sepsis1
- NQQ · System, Imaging, Optical Coherence Tomography (Oct)1
- GXY · Electrode, Cutaneous1
- OBJ · Catheter, Ultrasound, Intravascular1
- SHQ · Dental Image Analyzer, In-Office1
- POV · Semen Analysis Device1
- SHP · Cardiac Amyloidosis Machine Learning-Based Notification Software1
- SAT · Pulmonary Hypertension Machine Learning-Based Notification Software1
- HAW · Neurological Stereotaxic Instrument1
- SHL · Ear, Nose, And Throat Image Analyzer1
- PBZ · Image Processing Device For Estimation Of External Blood Loss1
- QZF · Gastrointestinal Capsule Endoscopy Analysis Software Device1
- QPF · Pediatric Autism Spectrum Disorder Diagnosis Aid1
- SHH · Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer1
- DXH · Transmitters And Receivers, Electrocardiograph, Telephone1
- OLO · Orthopedic Stereotaxic Instrument1
- SHE · Radiological Software System For Delivery Date Prediction1
- GKZ · Counter, Differential Cell1
- QME · Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate1
- DSI · Detector And Alarm, Arrhythmia1
- DRG · Transmitters And Receivers, Physiological Signal, Radiofrequency1
- PPU · Microbial Colony Image Assessment System1
- OUO · Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance1
- IYE · Accelerator, Linear, Medical1
- GWF · Stimulator, Electrical, Evoked Response1
- MHX · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1
Panels
Companies with more than one device here
- Philips Ultrasound, LLC5
- Siemens Medical Solutions USA, Inc.5
- Ge Medical Systems, LLC5
- Shanghai United Imaging Healthcare Co., Ltd.5
- Canon Medical Systems Corporation4
- Aidoc Medical , Ltd.4
- Philips Medical Systems Nederland B.V.4
- Anumana, Inc.3
- Tyto Care , Ltd.3
- Neurophet., Inc.3
- Siemens Healthcare GmbH3
- Esaote, S.p.A.3
- GE Medical Systems Ultrasound and Primary Care Diagnostics3
- Siemens Healthineers AG2
- DeepHealth, Inc.2
- Covidien, LLC2
- Sonio2
- Fujifilm Corporation2
- Wuhan United Imaging Healthcare Co.,Ltd2
- Subtle Medical, Inc.2
- Lunit, Inc.2
- Ever Fortune.Ai, Co., Ltd.2
- Medtronic Navigation, Inc.2
- BunkerHill Health2
- Elekta Solutions AB2
The newest 150 devices
181 devices authorized in 2026 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 |
|---|---|---|---|---|---|
| Auto-SegK253628 · 510(k) | Agada Medical, Ltd. | Radiology | QIH | database entry | |
| ADAS 3DK253969 · 510(k) | Adas3D Medical S.L. | Radiology | QIH | database entry | |
| Alturion Series Diagnostic Ultrasound SystemK260667 · 510(k) | Philips Ultrasound, LLC | Radiology | IYN | database entry | |
| SOMNUMK253390 · 510(k) | Honeynaps Co., Ltd. | Neurology | OLZ | database entry | |
| MammoScreenK260714 · 510(k) | Therapixel | Radiology | QDQ | database entry | |
| syngo.CT Coronary CockpitK253786 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | QIH | database entry | |
| Enhanced Boundary for PCCTK253560 · 510(k) | Ge Medical Systems, LLC | Radiology | JAK | database entry | |
| RX-1 SleepK253148 · 510(k) | Vivaquant, Inc. Dba Rhythm Express | Anesthesiology | MNR | database entry | |
| CMN Capillary Function with Oncology Virtual ExpK260316 · 510(k) | Cercare Medical A/S | Radiology | QIH | database entry | |
| RadOncAIK253050 · 510(k) | Informai | Radiology | MUJ | database entry | |
| ARTHURK260190 · 510(k) | ROPCA ApS | Radiology | IYO | database entry | |
| Vascular Assist Occlusion TriageK260729 · 510(k) | GuideAI Health | Radiology | QAS | database entry | |
| Synapse PACSK261713 · 510(k) | FUJIFILM Healthcare Americas Corporation | Radiology | QIH | database entry | |
| ACUSON Sequoia Diagnostic Ultrasound SystemK260844 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | IYN | database entry | |
| MediAI-OAK253172 · 510(k) | Crescom Co., Ltd. | Radiology | QIH | database entry | |
| LungMapsK253690 · 510(k) | Siemens Healthineers AG | Radiology | QIH | database entry | |
| Saige-DxK253825 · 510(k) | DeepHealth, Inc. | Radiology | QDQ | database entry | |
| WatchMate SoftwareK260300 · 510(k) | Anumana, Inc. | Radiology | QIH | database entry | |
| Brainomix 360 HyperdensityK260406 · 510(k) | Brainomix Limited | Radiology | QIH | database entry | |
| Acorn 3D SoftwareK260322 · 510(k) | Mighty Oak Medical | Radiology | QIH | database entry | |
| DeepXray SpinaK253192 · 510(k) | Alpha Intelligence Manifolds, Inc. | Radiology | SAO | database entry | |
| EchoNextK260332 · 510(k) | Pathwai, Inc. | Cardiovascular | QXO | database entry | |
| Instrument Exit Point on Touch Surgery AideK253984 · 510(k) | Covidien, LLC | Gastroenterology-Urology | SFE | database entry | |
| DEEPVESSEL PlaqueK260497 · 510(k) | Keya Medical Technology Co., Ltd. | Radiology | QIH | database entry | |
| Sonio SuspectK261519 · 510(k) | Sonio | Radiology | POK | database entry | |
| MeRT SystemK260402 · 510(k) | Wave Neuroscience | Neurology | SIG | database entry | |
| HeartFocusK260780 · 510(k) | Deski | Radiology | QJU | database entry | |
| Tyto Insights for Wheeze DetectionK252844 · 510(k) | Tyto Care , Ltd. | Anesthesiology | PHZ | database entry | |
| ZEUS PlatformK252859 · 510(k) | iRhythm Technologies, Inc. | Cardiovascular | DQK | database entry | |
| HistoSonics Planning ToolK252947 · 510(k) | HistoSonics, Inc. | Radiology | QTZ | database entry | |
| OrthoGrid Hip AI 4.0K260077 · 510(k) | OrthoGrid Systems, Inc. | Radiology | QIH | database entry | |
| GI Genius Module 300K261369 · 510(k) | Cosmo Artificial Intelligence - Ai, Ltd. | Gastroenterology-Urology | QNP | database entry | |
| ANDI 2.2K261405 · 510(k) | Imeka Solutions, Inc. | Radiology | QIH | database entry | |
| Synapse Lung Nodule AIK254075 · 510(k) | Fujifilm Corporation | Radiology | OEB | database entry | |
| EPIQ Series Diagnostic Ultrasound SystemK260123 · 510(k) | Philips Ultrasound, LLC | Radiology | IYN | database entry | |
| EPIQ Series Diagnostic Ultrasound SystemsK260680 · 510(k) | Philips Ultrasound, LLC | Radiology | IYN | database entry | |
| PCWP Analysis SoftwareDEN250057 · De Novo | Cardiosense, Inc. | Cardiovascular | SIF | database entry | |
| uMR AstraK260113 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | LNH | database entry | |
| Vitrea CT Transcatheter Aortic Valve ReplacementK260324 · 510(k) | Canon Medical Informatics, Inc. | Radiology | QIH | database entry | |
| uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE VitK253720 · 510(k) | Wuhan United Imaging Healthcare Co.,Ltd | Radiology | IYN | database entry | |
| BACK254131 · 510(k) | DeepHealth, Inc. | Radiology | QIH | database entry | |
| MSK GoK260234 · 510(k) | Smart Alfa Teknoloji San. Ve Tic. A.S. | Radiology | QIH | database entry | |
| DeepView AI SystemDEN250028 · De Novo | spectralmd, inc. | General and Plastic Surgery | SHY | database entry | |
| Aquilion ONEK253596 · 510(k) | Canon Medical Systems Corporation | Radiology | JAK | database entry | |
| Embryo PredictK250781 · 510(k) | Alife Health | Obstetrics and Gynecology | PBH | database entry | |
| Neurophet SCALE PETK252563 · 510(k) | Neurophet., Inc. | Radiology | QIH | database entry | |
| uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUEK253716 · 510(k) | Wuhan United Imaging Healthcare Co.,Ltd | Radiology | IYN | database entry | |
| SubtleHD-CTK254120 · 510(k) | Subtle Medical, Inc. | Radiology | QIH | database entry | |
| Neurophet AQUAK261273 · 510(k) | Neurophet., Inc. | Radiology | QIH | database entry | |
| UNiD Spine AnalyzerK261289 · 510(k) | Medicrea International S.A.S. (Medtronic) | Radiology | QIH | database entry | |
| SubtleHD-PETK254013 · 510(k) | Subtle Medical, Inc. | Radiology | LLZ | database entry | |
| BriefCase-TriageK261317 · 510(k) | Aidoc Medical , Ltd. | Radiology | QAS | database entry | |
| MorphK260032 · 510(k) | BeauBrain Healthcare, Inc. | Radiology | QIH | database entry | |
| RayvolveK260378 · 510(k) | AZmed | Radiology | QBS | database entry | |
| Velmeni for DentistsK252953 · 510(k) | Velmeni, Inc. | Radiology | MYN | database entry | |
| LingOral Dental Design SystemK260419 · 510(k) | Hangzhou ChohoTech Co., Ltd. | Dental | PNN | database entry | |
| Veritas Reverse Total Shoulder SystemK253992 · 510(k) | Restor3D | Orthopedic | PHX | database entry | |
| Lumify Diagnostic Ultrasound SystemK252558 · 510(k) | Philips Ultrasound, LLC | Radiology | IYN | database entry | |
| MammoSightAIK252954 · 510(k) | Neurocareai, Inc. (Dba Savelife.Ai) | Radiology | QFM | database entry | |
| ArteraAI BreastK254115 · 510(k) | Artera, Inc. | Pathology | SHW | database entry | |
| Capnostream35 Portable Respiratory MonitorK253030 · 510(k) | Covidien, LLC | Anesthesiology | CCK | database entry | |
| Bayesian Health Sepsis Flagging DeviceK250680 · 510(k) | Bayesian Health, Inc. | General Hospital | SAK | database entry | |
| Intelligent NRK252503 · 510(k) | Canon, Inc. | Radiology | OWB | database entry | |
| Synapse 3D Base ToolsK254189 · 510(k) | Fujifilm Corporation | Radiology | QIH | database entry | |
| DeepHealth ProstateAIK253682 · 510(k) | Quantib B.V. | Radiology | QDQ | database entry | |
| syngo Application SoftwareK254184 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | QIH | database entry | |
| CASSIEK252628 · 510(k) | Wesper, Inc. | Anesthesiology | MNR | database entry | |
| OPTIS Mobile Next Imaging SystemK253459 · 510(k) | ABBOTT MEDICAL | Radiology | NQQ | database entry | |
| Lunit INSIGHT MMGK260320 · 510(k) | Lunit, Inc. | Radiology | QDQ | database entry | |
| DS Core CBCT AnatomyK260785 · 510(k) | Dentsply Sirona | Radiology | QIH | database entry | |
| uOmnispace.MRK253077 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | QIH | database entry | |
| EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEMK253163 · 510(k) | Ever Fortune.Ai, Co., Ltd. | Radiology | QAS | database entry | |
| myosmart.K253256 · 510(k) | Otto Bock Healthcare Products GmbH | Neurology | GXY | database entry | |
| FolliscanK252332 · 510(k) | Mim Fertility | Radiology | QIH | database entry | |
| EdgeFlow UW20K252237 · 510(k) | Edgecare, Inc. | Radiology | IYO | database entry | |
| Novasight Hybrid SystemK252945 · 510(k) | Conavi Medical, Inc. | Cardiovascular | OBJ | database entry | |
| Critical Care Suite with Enteric Tube PositioninK253502 · 510(k) | Ge Medical Systems, LLC | Radiology | QIH | database entry | |
| DeepBT Detector-PlusK252190 · 510(k) | Aitewan Biomedical Technology, Inc. | Radiology | QKB | database entry | |
| AI-Rad Companion Organs RTK252548 · 510(k) | Siemens Healthcare GmbH | Radiology | QKB | database entry | |
| Relu CloudK252708 · 510(k) | Relu BV | Radiology | QIH | database entry | |
| syngo DynamicsK253689 · 510(k) | Siemens Healthcare GmbH | Radiology | QIH | database entry | |
| Overjet Iris Intelligent Imaging SystemK253930 · 510(k) | Overjet, Inc. | Radiology | QIH | database entry | |
| TRIOS DxK260082 · 510(k) | 3Shape TRIOS A/S | Dental | SHQ | database entry | |
| Seaman Pro/SeamanK252228 · 510(k) | Checkcells, Inc. | Hematology | POV | database entry | |
| ECG-AI Cardiac AmyloidosisK253801 · 510(k) | Anumana, Inc. | Cardiovascular | SHP | database entry | |
| 6450 Ultrasound SystemK253288 · 510(k) | Esaote, S.p.A. | Radiology | IYN | database entry | |
| uMI PanvivoK260524 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | KPS | database entry | |
| MAGENTIQ-COLOK260724 · 510(k) | Magentiq Eye, Ltd. | Gastroenterology-Urology | QNP | database entry | |
| CoLumbo C-SpineK254015 · 510(k) | Smart Soft Healthcare AD | Radiology | QIH | database entry | |
| AiORTA - Plan v2.0K254207 · 510(k) | ViTAA Medical Solutions, Inc. | Radiology | QIH | database entry | |
| ECG-AI Pulmonary HypertensionK252360 · 510(k) | Anumana, Inc. | Cardiovascular | SAT | database entry | |
| Spectral CT Verida FamilyK253649 · 510(k) | Philips Medical Systems Technologies , Ltd. | Radiology | JAK | database entry | |
| Butterfly Gestational Age ToolK252148 · 510(k) | Butterfly Network, Inc. | Radiology | IYN | database entry | |
| Automated Aortic Stenosis SoftwareK254161 · 510(k) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | Radiology | POK | database entry | |
| EPIQ Series Diagnostic Ultrasound System, AffiniK253595 · 510(k) | Philips Ultrasound, LLC | Radiology | IYN | database entry | |
| Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 withK253625 · 510(k) | Canon Medical Systems Corporation | Radiology | LNH | database entry | |
| S-scan OpenK260746 · 510(k) | Esaote, S.p.A. | Radiology | LNH | database entry | |
| Contour ProtégéAI+K253270 · 510(k) | Mim Software, Inc. | Radiology | QKB | database entry | |
| Stealth AXiS Cranial clinical applicationK253379 · 510(k) | Medtronic Navigation, Inc. | Neurology | HAW | database entry | |
| Lunit INSIGHT DBTK253796 · 510(k) | Lunit, Inc. | Radiology | QDQ | database entry | |
| SwiftMRK253775 · 510(k) | Airs Medical, Inc. | Radiology | QIH | database entry | |
| TriniasK252099 · 510(k) | Shimadzu Corporation | Radiology | OWB | database entry | |
| JLK-NCCTK252421 · 510(k) | JLK, Inc. | Radiology | QAS | database entry | |
| LOGIQ VitaK260673 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN | database entry | |
| CT Rembra RTK252992 · 510(k) | Philips Healthcare (Suzhou) Co., Ltd. | Radiology | JAK | database entry | |
| True Definition DLK253686 · 510(k) | Ge Healthcare Japan Corporation | Radiology | JAK | database entry | |
| Photonova Spectra, Photonova Spectra SelectK253520 · 510(k) | Ge Medical Systems, LLC | Radiology | JAK | database entry | |
| SOMATOM X.citeK253574 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | JAK | database entry | |
| AutoContourK260509 · 510(k) | Radformation, Inc. | Radiology | QKB | database entry | |
| syngo.via RT Image Suite VC10K252304 · 510(k) | Varian Medical Systems, Inc. | Radiology | MUJ | database entry | |
| Tyto Insights for Eardrum Bulging DetectionDEN250014 · De Novo | Tyto Care , Ltd. | Ear Nose & Throat | SHL | database entry | |
| EchoNavigator R5.0K253614 · 510(k) | Philips Medical Systems Nederland B.V. | Radiology | QIH | database entry | |
| SurgiCount+ SystemK252282 · 510(k) | Stryker Instruments | General Hospital | PBZ | database entry | |
| Data Analysis Facilitation SuiteK253944 · 510(k) | Voronoi Health Analytics Incorporated | Radiology | QIH | database entry | |
| Sonio DetectK252433 · 510(k) | Sonio | Radiology | IYN | database entry | |
| InferCare RECISTK252261 · 510(k) | Beijing Infervision Healthcare Medical Technology Co., Ltd. | Radiology | QIH | database entry | |
| Aquilion ServeSPK260078 · 510(k) | Canon Medical Systems Corporation | Radiology | JAK | database entry | |
| Tyto StethoscopeK252089 · 510(k) | Tyto Care , Ltd. | Cardiovascular | DQD | database entry | |
| Deep CapsuleK250655 · 510(k) | Digestaid - Artificial Intelligence Development SA | Gastroenterology-Urology | QZF | database entry | |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 withK253584 · 510(k) | Canon Medical Systems Corporation | Radiology | OWB | database entry | |
| LiverMultiScanK253413 · 510(k) | Perspectum, Ltd. | Radiology | LNH | database entry | |
| Onera SleepMapK253668 · 510(k) | Onera B.V. | Neurology | OLZ | database entry | |
| Bunkerhill Contrast CACK260166 · 510(k) | BunkerHill Health | Radiology | JAK | database entry | |
| Bunkerhill Contrast AVCK260167 · 510(k) | BunkerHill Health | Radiology | JAK | database entry | |
| VELYS Hip NavigationK253551 · 510(k) | Depuy Ireland UC | Radiology | QIH | database entry | |
| EarliPoint AssessmentK253442 · 510(k) | Earlitec Diagnostics | Neurology | QPF | database entry | |
| CEPHX3DK252538 · 510(k) | Orca Dental AI , Ltd. | Radiology | QIH | database entry | |
| AV Cardiac CTK260169 · 510(k) | Philips Medical Systems Nederland B.V. | Radiology | JAK | database entry | |
| Magnifico OpenK251901 · 510(k) | Esaote, S.p.A. | Radiology | LNH | database entry | |
| QT Scanner 2000 Model AK253898 · 510(k) | QT Imaging Holdings, Inc. | Radiology | IYO | database entry | |
| Claire OCT SystemP250008 · PMA | Perimeter Medical Imaging Ai, Inc. | General and Plastic Surgery | SHH | database entry | |
| Annalise EnterpriseK253818 · 510(k) | Harrison-AI Medical Pty, Ltd. | Radiology | QAS | database entry | |
| Clarius Ejection Fraction AIK253593 · 510(k) | Clarius Mobile Health Corp. | Radiology | QIH | database entry | |
| Ligence HeartK253535 · 510(k) | Ligence Uab | Radiology | QIH | database entry | |
| BriefCase-Triage: CARE Multi-Triage CT for PneumK253578 · 510(k) | Aidoc Medical , Ltd. | Radiology | QAS | database entry | |
| AI Platform 2.2K260217 · 510(k) | Exo Imaging | Radiology | QIH | database entry | |
| Ingenia, Ingenia CX, Ingenia Elition S/X, IngeniK253648 · 510(k) | Philips Medical Systems Nederland B.V. | Radiology | LNH | database entry | |
| MAGNETOM Flow.AceK260265 · 510(k) | Siemens Shenzhen Magnetic Resonance , Ltd. | Radiology | LNH | database entry | |
| CARTO 3 EP Navigation System V8.4K252972 · 510(k) | Biosense Webster, Inc. | Cardiovascular | DQK | database entry | |
| CARA SystemK252500 · 510(k) | Cara Medical, Ltd. | Radiology | OWB | database entry | |
| Monaco RTP SystemK252002 · 510(k) | Elekta Solutions AB | Radiology | MUJ | database entry | |
| PreemptiveAI Clinical SDKK250233 · 510(k) | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | Cardiovascular | DXH | database entry | |
| uMI PanvivoK253564 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | KPS | database entry | |
| Stealth AXiS Surgical System with Stealth AXiS SK253381 · 510(k) | Medtronic Navigation, Inc. | Neurology | OLO | database entry | |
| Delivery Date AIDEN250007 · De Novo | Ultrasound AI | Radiology | SHE | database entry | |
| AI4CMR v2.0K252084 · 510(k) | Ai4medimaging Medical Solutions S.A. | Radiology | QIH | database entry | |
| MI View&GOK254016 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | QIH | database entry | |
| Kneevoice Cartilage Evaluation SystemK252076 · 510(k) | Kneevoice, Inc. | Cardiovascular | DQD | database entry | |
| SafeBeat Rx AppK251218 · 510(k) | SafeBeat Rx, Inc. | Cardiovascular | DQK | database entry | |
| Athelas HomeK243348 · 510(k) | Athelas, Inc. | Hematology | GKZ | database entry |
Every year in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.