Every 510(k) and De Novo clearance for AI and ML medical devices — search by device name, company, or K-number.
| K-Number | Device | Company | Indication | Date | Type |
|---|---|---|---|---|---|
| K260851 | Better Diagnostics Dental Assist (BDDA) Version 1.0 | Better Diagnostics AI Corp. | Radiology | Jul 15, 2026 | 510(k) |
| K260378 | Rayvolve | AZmed | General | May 12, 2026 | 510(k) |
| K252953 | Velmeni for Dentists (V4D) Endo-Perio | Velmeni, Inc. | Radiology | May 11, 2026 | 510(k) |
| K251934 | qXR-Detect | Qure.Ai Technologies | Radiology | Jan 16, 2026 | 510(k) |
| K252934 | Diagnocat | DGNCT, LLC | Radiology | Jan 15, 2026 | 510(k) |
| K253009 | DS Core Detect | Dentsply Sirona, Inc. | Radiology | Jan 7, 2026 | 510(k) |
| K252086 | DTX Studio Assist | Nobel Biocare C/O Medicim NV | Radiology | Nov 17, 2025 | 510(k) |
| K250525 | Second Opinion® Panoramic | Pearl, Inc. | Radiology | Nov 14, 2025 | 510(k) |
| K250264 | SugarBug (1.x) | Bench7, Inc. | Radiology | Nov 7, 2025 | 510(k) |
| K251002 | Videa Dental AI | Videahealth, Inc. | Radiology | Sep 19, 2025 | 510(k) |
| K250753 | VELMENI for DENTISTS (V4D) | Velmeni, Inc. | Radiology | Sep 2, 2025 | 510(k) |
| K243234 | Second Opinion® CS | Pearl, Inc. | Radiology | Jun 12, 2025 | 510(k) |
| K242437 | Smile Dx® | Cube Click, Inc. | Radiology | May 14, 2025 | 510(k) |
| K243893 | Second Opinion® Pediatric | Pearl, Inc. | Radiology | May 5, 2025 | 510(k) |
| K243239 | Lung AI (LAI001) | Exo, Inc. | Radiology | Apr 24, 2025 | 510(k) |
| K242600 | Second Opinion Periapical Radiolucency Contours | Pearl, Inc. | Radiology | Apr 11, 2025 | 510(k) |
| K243831 | Rayvolve LN | AZmed | Radiology | Mar 26, 2025 | 510(k) |
| K241725 | Better Diagnostics Caries Assist (BDCA) Version 1.0 | Better Diagnostics AI Corp. | Radiology | Mar 11, 2025 | 510(k) |
| K241620 | ChestView US | Gleamer Sas | Radiology | Feb 27, 2025 | 510(k) |
| K242171 | TechCare Trauma | Milvue | General | Jan 17, 2025 | 510(k) |
| K242522 | Second Opinion CC | Pearl, Inc. | Radiology | Jan 16, 2025 | 510(k) |
| K240712 | icobrain aria | Icometrix NV | General | Nov 7, 2024 | 510(k) |
| K240003 | Velmeni for Dentists (V4D) | Velmeni, Inc. | Radiology | Aug 30, 2024 | 510(k) |
| K240845 | Rayvolve | Azmed Sas | General | Jul 17, 2024 | 510(k) |
| K233738 | Overjet Caries Assist-Pediatric | Overjet, Inc. | Radiology | Mar 4, 2024 | 510(k) |
| K231805 | qXR-LN | Qure.Ai Technologies | Radiology | Dec 22, 2023 | 510(k) |
| K232384 | Videa Dental Assist | Videahealth, Inc. | Radiology | Dec 15, 2023 | 510(k) |
| K230144 | Denti.AI Detect | Denti.Ai Technology, Inc. | Radiology | Oct 6, 2023 | 510(k) |
| K231001 | DeepTek CXR Analyzer v1.0 | Deeptek Medical Imaging Pvt, Ltd. | Radiology | Oct 5, 2023 | 510(k) |
| K230085 | Lung-CAD | Imagen Technologies, Inc. | Radiology | Oct 3, 2023 | 510(k) |
| K231678 | Overjet Periapical Radiolucency Assist | Overjet, Inc. | Radiology | Sep 21, 2023 | 510(k) |
| K223811 | Lung-CAD | Imagen Technologies, Inc. | Radiology | Sep 13, 2023 | 510(k) |
| K223133 | VisiRad XR | Imidex, Inc. | Radiology | Aug 3, 2023 | 510(k) |
| K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite | Ge Medical Systems, LLC | General | May 25, 2023 | 510(k) |
| K221921 | DTX Studio Clinic 3.0 | Nobel Biocare AB | Radiology | Mar 28, 2023 | 510(k) |
| K222746 | Overjet Caries Assist | Overjet, Inc. | Radiology | Mar 27, 2023 | 510(k) |
| K222176 | BoneView | Gleamer | General | Mar 2, 2023 | 510(k) |
| K220928 | Overjet Calculus Assist | Overjet, Inc. | Radiology | Dec 16, 2022 | 510(k) |
| K213353 | Aorta-CAD | Imagen Technologies, Inc. | Radiology | Sep 20, 2022 | 510(k) |
| K220164 | Rayvolve | Azmed Sas | General | Jun 2, 2022 | 510(k) |
| K212519 | Overjet Caries Assist | Overjet, Inc. | Radiology | May 10, 2022 | 510(k) |
| K213795 | Videa Caries Assist | Videahealth, Inc. | Radiology | Apr 21, 2022 | 510(k) |
| K210365 | Second Opinion | Pearl, Inc. | Radiology | Mar 4, 2022 | 510(k) |
| K212365 | BoneView | Gleamer | General | Mar 1, 2022 | 510(k) |
| K201560 | Auto Lung Nodule Detection | Samsung Electronics Co., Ltd. | Radiology | Aug 31, 2021 | 510(k) |
| K210666 | Chest-CAD | Imagen Technologies, Inc. | Radiology | Jul 20, 2021 | 510(k) |
| DEN190035 | Helix Laboratory Platform | Helix Opco, LLC | Pulmonary | Dec 23, 2020 | 510(k) |
| K193417 | FractureDetect (FX) | Imagen Technologies, Inc. | General | Jul 30, 2020 | 510(k) |
| DEN180012 | LOADPRO Intraoperative Rod Strain Sensor | Intellirod Spine, Inc. | Cardiology | Mar 28, 2019 | 510(k) |
| DEN180005 | OsteoDetect | Imagen Technologies, Inc. | General | May 24, 2018 | 510(k) |
| K172128 | EsoFLIP® ES-310 Balloon Catheter | Crospon, Ltd. | General | Nov 22, 2017 | 510(k) |
| K142000 | ESOFLIP ES | Crospon, Ltd. | General | Sep 25, 2014 | 510(k) |
| K120986 | STRATIFY JCV DXSELECT | Focus Diagnostics, Inc. | GI | Aug 16, 2012 | 510(k) |
| DEN120008 | STRATIFY JCV(TM) ANTIBODY | Focus Diagnostics, Inc. | GI | Jan 20, 2012 | 510(k) |