HealthMammo is an AI-enabled medical device from Zebra Medical Vision Ltd., listed by FDA (510(k), K200905) with a decision date of 2020-07-16. Review panel: Radiology.
| FDA submission number | K200905 |
|---|---|
| Pathway | 510(k) |
| Company | Zebra Medical Vision Ltd. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2020-07-16 |
| Decision | Substantially Equivalent |
| Product code | QFM |
| Classification | Radiological Computer-Assisted Prioritization Software For Lesions |
| Device class | 2 |
| Regulation number | 892.2080 |
| Review time (calendar days) | 101 |
| Applicant country | IL |
Official FDA database record · FDA AI-enabled device list
More devices from Zebra Medical Vision Ltd. · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.