MYN — Analyzer, Medical Image Class II
FDA product code MYN covers "Analyzer, Medical Image", a Class II medical device regulated under 21 CFR 892.2070. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MYN
- Device Class
- Class II
- Regulation Number
- 892.2070
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260851 | better diagnostics ai | Better Diagnostics Dental Assist (BDDA) Version 1.0 | July 15, 2026 |
| K252953 | velmeni | Velmeni for Dentists (V4D) Endo-Perio | May 11, 2026 |
| K251934 | qure.ai technologies | qXR-Detect | January 16, 2026 |
| K252934 | dgnct | Diagnocat | January 15, 2026 |
| K253009 | dentsply sirona | DS Core Detect | January 7, 2026 |
| K252086 | nobel biocare c/o medicim | DTX Studio Assist | November 17, 2025 |
| K250525 | pearl | Second Opinion® Panoramic | November 14, 2025 |
| K250264 | bench7 | SugarBug (1.x) | November 7, 2025 |
| K251002 | videahealth | Videa Dental AI | September 19, 2025 |
| K250753 | velmeni | VELMENI for DENTISTS (V4D) | September 2, 2025 |
| K243234 | pearl | Second Opinion® CS | June 12, 2025 |
| K242437 | cube click | Smile Dx® | May 14, 2025 |
| K243893 | pearl | Second Opinion® Pediatric | May 5, 2025 |
| K243239 | exo | Lung AI (LAI001) | April 24, 2025 |
| K242600 | pearl | Second Opinion Periapical Radiolucency Contours | April 11, 2025 |
| K243831 | azmed | Rayvolve LN | March 26, 2025 |
| K241725 | better diagnostics ai | Better Diagnostics Caries Assist (BDCA) Version 1.0 | March 11, 2025 |
| K241620 | gleamer | ChestView US | February 27, 2025 |
| K242522 | pearl | Second Opinion CC | January 16, 2025 |
| K240003 | velmeni | Velmeni for Dentists (V4D) | August 30, 2024 |