K241725 is an FDA 510(k) clearance for the Better Diagnostics Caries Assist (BDCA) Version 1.0. This device is classified as a Analyzer, Medical Image (Class II - Special Controls, product code MYN).
Submitted by Better Diagnostics AI Corp. (Avon, US). The FDA issued a Cleared decision on March 11, 2025, 270 days after receiving the submission on June 14, 2024.
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 | K241725 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2024 |
| Decision Date | March 11, 2025 |
| Days to Decision | 270 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 |