aPROMISE is an AI-enabled medical device from EXINI Diagnostics AB, listed by FDA (510(k), K211655) with a decision date of 2021-07-27. Review panel: Radiology.
| FDA submission number | K211655 |
|---|---|
| Pathway | 510(k) |
| Company | EXINI Diagnostics AB |
| Review panel (specialty) | Radiology |
| FDA decision date | 2021-07-27 |
| Decision | Substantially Equivalent |
| Product code | LLZ |
| Classification | System, Image Processing, Radiological |
| Device class | 2 |
| Regulation number | 892.2050 |
| Review time (calendar days) | 60 |
| Applicant country | SE |
Official FDA database record · FDA AI-enabled device list
More devices from EXINI Diagnostics AB · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.