K240003 is an FDA 510(k) clearance for the Velmeni for Dentists (V4D). This device is classified as a Analyzer, Medical Image (Class II - Special Controls, product code MYN).
Submitted by Velmeni, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 30, 2024, 241 days after receiving the submission on January 2, 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 | K240003 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2024 |
| Decision Date | August 30, 2024 |
| Days to Decision | 241 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 |