MVision AI Segmentation is an AI-enabled medical device from MVision AI, listed by FDA (510(k), K212915) with a decision date of 2022-05-03. Review panel: Radiology.
| FDA submission number | K212915 |
|---|---|
| Pathway | 510(k) |
| Company | MVision AI |
| Review panel (specialty) | Radiology |
| FDA decision date | 2022-05-03 |
| Decision | Substantially Equivalent |
| Product code | QKB |
| Classification | Radiological Image Processing Software For Radiation Therapy |
| Device class | 2 |
| Regulation number | 892.2050 |
| Review time (calendar days) | 232 |
| Applicant country | FI |
Official FDA database record · FDA AI-enabled device list
All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.