FDA Product Code
FDA Product Code MYN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.2070
510(k) Clearances — 40 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252486 | ChestView US (1.1) | Gleamer | 2026-09-09 | Traditional | PDF ↗ |
| K261059 | Overjet Multi-Image Caries and Charting Assist | Overjet, Inc. | 2026-08-06 | Traditional | PDF ↗ |
| K260851 | Better Diagnostics Dental Assist (BDDA) Version 1.0 | Better Diagnostics AI Corp. | 2026-07-15 | Traditional | PDF ↗ |
| K252953 | Velmeni for Dentists (V4D) Endo-Perio | Velmeni, Inc. | 2026-05-11 | Traditional | PDF ↗ |
| K251934 | qXR-Detect | Qure.Ai Technologies | 2026-01-16 | Traditional | PDF ↗ |
| K252934 | Diagnocat | DGNCT, LLC | 2026-01-15 | Traditional | PDF ↗ |
| K253009 | DS Core Detect | Dentsply Sirona, Inc. | 2026-01-07 | Traditional | PDF ↗ |
| K252086 | DTX Studio Assist | Nobel Biocare C/O Medicim NV | 2025-11-17 | Traditional | PDF ↗ |
| K250525 | Second Opinion® Panoramic | Pearl, Inc. | 2025-11-14 | Traditional | PDF ↗ |
| K250264 | SugarBug (1.x) | Bench7, Inc. | 2025-11-07 | Traditional | PDF ↗ |
| K251002 | Videa Dental AI | Videahealth, Inc. | 2025-09-19 | Traditional | PDF ↗ |
| K250753 | VELMENI for DENTISTS (V4D) | Velmeni, Inc. | 2025-09-02 | Traditional | PDF ↗ |
| K243234 | Second Opinion® CS | Pearl, Inc. | 2025-06-12 | Traditional | PDF ↗ |
| K242437 | Smile Dx® | Cube Click, Inc. | 2025-05-14 | Traditional | PDF ↗ |
| K243893 | Second Opinion® Pediatric | Pearl, Inc. | 2025-05-05 | Traditional | PDF ↗ |
| K243239 | Lung AI (LAI001) | Exo, Inc. | 2025-04-24 | Traditional | PDF ↗ |
| K242600 | Second Opinion Periapical Radiolucency Contours | Pearl, Inc. | 2025-04-11 | Traditional | PDF ↗ |
| K243831 | Rayvolve LN | AZmed | 2025-03-26 | Traditional | PDF ↗ |
| K241725 | Better Diagnostics Caries Assist (BDCA) Version 1.0 | Better Diagnostics AI Corp. | 2025-03-11 | Traditional | PDF ↗ |
| K241620 | ChestView US | Gleamer Sas | 2025-02-27 | Traditional | PDF ↗ |
| K242522 | Second Opinion CC | Pearl, Inc. | 2025-01-16 | Traditional | PDF ↗ |
| K240003 | Velmeni for Dentists (V4D) | Velmeni, Inc. | 2024-08-30 | Traditional | PDF ↗ |
| K233738 | Overjet Caries Assist-Pediatric | Overjet, Inc. | 2024-03-04 | Traditional | PDF ↗ |
| K231805 | qXR-LN | Qure.Ai Technologies | 2023-12-22 | Traditional | PDF ↗ |
| K232384 | Videa Dental Assist | Videahealth, Inc. | 2023-12-15 | Traditional | PDF ↗ |
| K230144 | Denti.AI Detect | Denti.Ai Technology, Inc. | 2023-10-06 | Traditional | PDF ↗ |
| K231001 | DeepTek CXR Analyzer v1.0 | Deeptek Medical Imaging Pvt, Ltd. | 2023-10-05 | Traditional | PDF ↗ |
| K230085 | Lung-CAD | Imagen Technologies, Inc. | 2023-10-03 | Traditional | PDF ↗ |
| K231678 | Overjet Periapical Radiolucency Assist | Overjet, Inc. | 2023-09-21 | Traditional | PDF ↗ |
| K223811 | Lung-CAD | Imagen Technologies, Inc. | 2023-09-13 | Traditional | PDF ↗ |
| K223133 | VisiRad XR | Imidex, Inc. | 2023-08-03 | Traditional | PDF ↗ |
| K221921 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2023-03-28 | Traditional | PDF ↗ |
| K222746 | Overjet Caries Assist | Overjet, Inc. | 2023-03-27 | Traditional | PDF ↗ |
| K220928 | Overjet Calculus Assist | Overjet, Inc. | 2022-12-16 | Traditional | PDF ↗ |
| K213353 | Aorta-CAD | Imagen Technologies, Inc. | 2022-09-20 | Traditional | PDF ↗ |
| K212519 | Overjet Caries Assist | Overjet, Inc. | 2022-05-10 | Traditional | PDF ↗ |
| K213795 | Videa Caries Assist | Videahealth, Inc. | 2022-04-21 | Traditional | PDF ↗ |
| K210365 | Second Opinion | Pearl, Inc. | 2022-03-04 | Traditional | PDF ↗ |
| K201560 | Auto Lung Nodule Detection | Samsung Electronics Co., Ltd. | 2021-08-31 | Traditional | PDF ↗ |
| K210666 | Chest-CAD | Imagen Technologies, Inc. | 2021-07-20 | Traditional | PDF ↗ |
Product code MYN · Class II · Radiology. Data: openFDA.