ABMD Software is an AI-enabled medical device from HeartLung Corporation, listed by FDA (510(k), K213760) with a decision date of 2022-07-29. Review panel: Radiology.
| FDA submission number | K213760 |
|---|---|
| Pathway | 510(k) |
| Company | HeartLung Corporation |
| Review panel (specialty) | Radiology |
| FDA decision date | 2022-07-29 |
| Decision | Substantially Equivalent |
| Product code | KGI |
| Classification | Densitometer, Bone |
| Device class | 2 |
| Regulation number | 892.1170 |
| Review time (calendar days) | 240 |
| Applicant country | US |
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.