MYN — Analyzer, Medical Image Class II
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 |
|---|---|---|---|
| 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 |
| K233738 | overjet | Overjet Caries Assist-Pediatric | March 4, 2024 |
| K231805 | qure.ai technologies | qXR-LN | December 22, 2023 |