K213795 is an FDA 510(k) clearance for the Videa Caries Assist. 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 April 21, 2022, 136 days after receiving the submission on December 6, 2021.
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 | K213795 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2021 |
| Decision Date | April 21, 2022 |
| Days to Decision | 136 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 |