MYN
- Product code
- MYN
- Device name
- Analyzer, Medical Image
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.2070
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 29
- Summaries archived here
- 25 (direct download)
- 510(k) clearances (all years, FDA)
- 39 (all years; only the last 3 years are listed here)
FDA classification definition
For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers
510(k) clearances, last 3 years (29)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261059 | 2026-08-06 | Overjet, Inc. | Overjet Multi-Image Caries and Charting Assist | FDA |
| K260851 | 2026-07-15 | Better Diagnostics AI Corp. | Better Diagnostics Dental Assist (BDDA) Version 1.0 | |
| K252953 | 2026-05-11 | Velmeni, Inc. | Velmeni for Dentists (V4D) Endo-Perio | FDA |
| K251934 | 2026-01-16 | Qure.Ai Technologies | qXR-Detect | |
| K252934 | 2026-01-15 | DGNCT, LLC | Diagnocat | |
| K253009 | 2026-01-07 | Dentsply Sirona, Inc. | DS Core Detect | |
| K252086 | 2025-11-17 | Nobel Biocare C/O Medicim NV | DTX Studio Assist | |
| K250525 | 2025-11-14 | Pearl, Inc. | Second Opinion® Panoramic | |
| K250264 | 2025-11-07 | Bench7, Inc. | SugarBug (1.x) | |
| K251002 | 2025-09-19 | Videahealth, Inc. | Videa Dental AI | |
| K250753 | 2025-09-02 | Velmeni, Inc. | VELMENI for DENTISTS (V4D) | |
| K243234 | 2025-06-12 | Pearl, Inc. | Second Opinion® CS | |
| K242437 | 2025-05-14 | Cube Click, Inc. | Smile Dx® | |
| K243893 | 2025-05-05 | Pearl, Inc. | Second Opinion® Pediatric | FDA |
| K243239 | 2025-04-24 | Exo, Inc. | Lung AI (LAI001) | |
| K242600 | 2025-04-11 | Pearl, Inc. | Second Opinion Periapical Radiolucency Contours | |
| K243831 | 2025-03-26 | AZmed | Rayvolve LN | |
| K241725 | 2025-03-11 | Better Diagnostics AI Corp. | Better Diagnostics Caries Assist (BDCA) Version 1.0 | |
| K241620 | 2025-02-27 | Gleamer Sas | ChestView US | |
| K242522 | 2025-01-16 | Pearl, Inc. | Second Opinion CC | FDA |
| K240003 | 2024-08-30 | Velmeni, Inc. | Velmeni for Dentists (V4D) | |
| K233738 | 2024-03-04 | Overjet, Inc. | Overjet Caries Assist-Pediatric | |
| K231805 | 2023-12-22 | Qure.Ai Technologies | qXR-LN | |
| K232384 | 2023-12-15 | Videahealth, Inc. | Videa Dental Assist | |
| K230144 | 2023-10-06 | Denti.Ai Technology, Inc. | Denti.AI Detect | |
| K231001 | 2023-10-05 | Deeptek Medical Imaging Pvt, Ltd. | DeepTek CXR Analyzer v1.0 | |
| K230085 | 2023-10-03 | Imagen Technologies, Inc. | Lung-CAD | |
| K231678 | 2023-09-21 | Overjet, Inc. | Overjet Periapical Radiolucency Assist | |
| K223811 | 2023-09-13 | Imagen Technologies, Inc. | Lung-CAD |
Official FDA classification page: MYN
Classification and pathway per current FDA publications. Data from openFDA (CC0).