| Overjet Multi-Image Caries and Charting Assist (K261059) | Overjet, Inc. | 2026-08-06 |
| Better Diagnostics Dental Assist (BDDA) Version 1.0 (K260851) | Better Diagnostics AI Corp. | 2026-07-15 |
| Velmeni for Dentists (V4D) Endo-Perio (K252953) | Velmeni, Inc. | 2026-05-11 |
| qXR-Detect (K251934) | Qure.Ai Technologies | 2026-01-16 |
| Diagnocat (K252934) | DGNCT, LLC | 2026-01-15 |
| DS Core Detect (K253009) | Dentsply Sirona, Inc. | 2026-01-07 |
| DTX Studio Assist (K252086) | Nobel Biocare C/O Medicim NV | 2025-11-17 |
| Second Opinion® Panoramic (K250525) | Pearl, Inc. | 2025-11-14 |
| SugarBug (1.x) (K250264) | Bench7, Inc. | 2025-11-07 |
| Videa Dental AI (K251002) | Videahealth, Inc. | 2025-09-19 |
| VELMENI for DENTISTS (V4D) (K250753) | Velmeni, Inc. | 2025-09-02 |
| Second Opinion® CS (K243234) | Pearl, Inc. | 2025-06-12 |
| Smile Dx® (K242437) | Cube Click, Inc. | 2025-05-14 |
| Second Opinion® Pediatric (K243893) | Pearl, Inc. | 2025-05-05 |
| Lung AI (LAI001) (K243239) | Exo, Inc. | 2025-04-24 |
| Second Opinion Periapical Radiolucency Contours (K242600) | Pearl, Inc. | 2025-04-11 |
| Rayvolve LN (K243831) | AZmed | 2025-03-26 |
| Better Diagnostics Caries Assist (BDCA) Version 1.0 (K241725) | Better Diagnostics AI Corp. | 2025-03-11 |
| ChestView US (K241620) | Gleamer Sas | 2025-02-27 |
| Second Opinion CC (K242522) | Pearl, Inc. | 2025-01-16 |
| Velmeni for Dentists (V4D) (K240003) | Velmeni, Inc. | 2024-08-30 |
| Overjet Caries Assist-Pediatric (K233738) | Overjet, Inc. | 2024-03-04 |
| qXR-LN (K231805) | Qure.Ai Technologies | 2023-12-22 |
| Videa Dental Assist (K232384) | Videahealth, Inc. | 2023-12-15 |
| Denti.AI Detect (K230144) | Denti.Ai Technology, Inc. | 2023-10-06 |
| DeepTek CXR Analyzer v1.0 (K231001) | Deeptek Medical Imaging Pvt, Ltd. | 2023-10-05 |
| Lung-CAD (K230085) | Imagen Technologies, Inc. | 2023-10-03 |
| Overjet Periapical Radiolucency Assist (K231678) | Overjet, Inc. | 2023-09-21 |
| Lung-CAD (K223811) | Imagen Technologies, Inc. | 2023-09-13 |
| VisiRad XR (K223133) | Imidex, Inc. | 2023-08-03 |
| DTX Studio Clinic 3.0 (K221921) | Nobel Biocare AB | 2023-03-28 |
| Overjet Caries Assist (K222746) | Overjet, Inc. | 2023-03-27 |
| Overjet Calculus Assist (K220928) | Overjet, Inc. | 2022-12-16 |
| Aorta-CAD (K213353) | Imagen Technologies, Inc. | 2022-09-20 |
| Overjet Caries Assist (K212519) | Overjet, Inc. | 2022-05-10 |
| Videa Caries Assist (K213795) | Videahealth, Inc. | 2022-04-21 |
| Second Opinion (K210365) | Pearl, Inc. | 2022-03-04 |
| Auto Lung Nodule Detection (K201560) | Samsung Electronics Co., Ltd. | 2021-08-31 |
| Chest-CAD (K210666) | Imagen Technologies, Inc. | 2021-07-20 |