FDA 510(k) Applications for Medical Device Product Code "MYN"
(Analyzer,Medical Image)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K243831 | AZmed | Rayvolve LN | 03/26/2025 |
| K241725 | Better Diagnostics AI Corp | Better Diagnostics Caries Assist (BDCA) Version 1.0 | 03/11/2025 |
| K242437 | Cube Click, Inc. | Smile Dx« | 05/14/2025 |
| K231001 | DeepTek Medical Imaging Pvt Ltd | DeepTek CXR Analyzer v1.0 | 10/05/2023 |
| K230144 | Denti.AI Technology, Inc. | Denti.AI Detect | 10/06/2023 |
| K243239 | Exo Inc | Lung AI (LAI001) | 04/24/2025 |
| K241620 | Gleamer SAS | ChestView US | 02/27/2025 |
| K213353 | Imagen Technologies, Inc | Aorta-CAD | 09/20/2022 |
| K210666 | Imagen Technologies, Inc | Chest-CAD | 07/20/2021 |
| K223811 | Imagen Technologies, Inc | Lung-CAD | 09/13/2023 |
| K230085 | Imagen Technologies, Inc | Lung-CAD | 10/03/2023 |
| K223133 | Imidex Inc. | VisiRad XR | 08/03/2023 |
| K221921 | Nobel Biocare AB | DTX Studio Clinic 3.0 | 03/28/2023 |
| K220928 | Overjet Inc. | Overjet Calculus Assist | 12/16/2022 |
| K233738 | Overjet, Inc | Overjet Caries Assist-Pediatric | 03/04/2024 |
| K231678 | Overjet, Inc | Overjet Periapical Radiolucency Assist | 09/21/2023 |
| K212519 | Overjet, Inc. | Overjet Caries Assist | 05/10/2022 |
| K222746 | Overjet, Inc. | Overjet Caries Assist | 03/27/2023 |
| K210365 | Pearl Inc. | Second Opinion | 03/04/2022 |
| K242522 | Pearl Inc. | Second Opinion CC | 01/16/2025 |
| K242600 | Pearl Inc. | Second Opinion Periapical Radiolucency Contours | 04/11/2025 |
| K243234 | Pearl Inc. | Second Opinion« CS | 06/12/2025 |
| K243893 | Pearl, Inc. | Second Opinion« Pediatric | 05/05/2025 |
| K231805 | Qure.ai Technologies | qXR-LN | 12/22/2023 |
| K201560 | Samsung Electronics Co.,Ltd. | Auto Lung Nodule Detection | 08/31/2021 |
| K240003 | Velmeni Inc. | Velmeni for Dentists (V4D) | 08/30/2024 |
| K213795 | VideaHealth, Inc | Videa Caries Assist | 04/21/2022 |
| K232384 | VideaHealth, Inc. | Videa Dental Assist | 12/15/2023 |
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