The following data is part of a premarket notification filed by Videahealth, Inc with the FDA for Videa Caries Assist.
| Device ID | K213795 |
| 510k Number | K213795 |
| Device Name: | Videa Caries Assist |
| Classification | Analyzer, Medical Image |
| Applicant | VideaHealth, Inc 19 Kingston St Bostong, MA 02111 |
| Contact | Florian Hill |
| Correspondent | Donna-bea Tillman Biologics Consulting 1555 King St, Suite 300 Alexandria, VA 22314 |
| Product Code | MYN |
| CFR Regulation Number | 892.2070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-06 |
| Decision Date | 2022-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00196852162192 | K213795 | 000 |