AMRA Profiler is an AI-enabled medical device from AMRA Medical AB, listed by FDA (510(k), K173749) with a decision date of 2018-12-06. Review panel: Radiology.
| FDA submission number | K173749 |
|---|---|
| Pathway | 510(k) |
| Company | AMRA Medical AB |
| Review panel (specialty) | Radiology |
| FDA decision date | 2018-12-06 |
| Decision | Substantially Equivalent |
| Product code | LNH |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Device class | 2 |
| Regulation number | 892.1000 |
| Review time (calendar days) | 363 |
| 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.