K251002 is an FDA 510(k) clearance for the Videa Dental AI. This device is classified as a Analyzer, Medical Image (Class II - Special Controls, product code MYN).
Submitted by Videahealth, Inc. (Boston, US). The FDA issued a Cleared decision on September 19, 2025, 171 days after receiving the submission on April 1, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2070. 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) Number | K251002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2025 |
| Decision Date | September 19, 2025 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MYN - Analyzer, Medical Image |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2070 |
| 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 |