DTX Studio Clinic 3.0 is an AI-enabled medical device from Nobel Biocare AB, listed by FDA (510(k), K221921) with a decision date of 2023-03-28. Review panel: Radiology.
| FDA submission number | K221921 |
|---|---|
| Pathway | 510(k) |
| Company | Nobel Biocare AB |
| Review panel (specialty) | Radiology |
| FDA decision date | 2023-03-28 |
| Decision | Substantially Equivalent |
| Product code | MYN |
| Classification | Analyzer, Medical Image |
| Device class | 2 |
| Regulation number | 892.2070 |
| Review time (calendar days) | 270 |
| Applicant country | SE |
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.