SubtlePET is an AI-enabled medical device from Subtle Medical, Inc., listed by FDA (510(k), K211964) with a decision date of 2021-09-28. Review panel: Radiology.
| FDA submission number | K211964 |
|---|---|
| Pathway | 510(k) |
| Company | Subtle Medical, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2021-09-28 |
| Decision | Substantially Equivalent |
| Product code | KPS |
| Classification | System, Tomography, Computed, Emission |
| Device class | 2 |
| Regulation number | 892.1200 |
| Review time (calendar days) | 96 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
More devices from Subtle Medical, Inc. · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.