Koios DS for Breast is an AI-enabled medical device from Koios Medical, Inc., listed by FDA (510(k), K190442) with a decision date of 2019-07-03. Review panel: Radiology.
| FDA submission number | K190442 |
|---|---|
| Pathway | 510(k) |
| Company | Koios Medical, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2019-07-03 |
| Decision | Substantially Equivalent |
| Product code | POK |
| Classification | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Device class | 2 |
| Regulation number | 892.2060 |
| Review time (calendar days) | 128 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
More devices from Koios 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.