K210151 is an FDA 510(k) clearance for the Digimamo D. This device is classified as a Full Field Digital, System, X-ray, Mammographic (Class II - Special Controls, product code MUE).
Submitted by Vmi Tecnologias Ltda (Lagoa Santa, BR). The FDA issued a Cleared decision on March 1, 2022, 404 days after receiving the submission on January 21, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1715.
| 510(k) Number | K210151 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2021 |
| Decision Date | March 01, 2022 |
| Days to Decision | 404 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUE - Full Field Digital, System, X-ray, Mammographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1715 |