QP-Prostate® CAD is an AI-enabled medical device from Quibim S.L., listed by FDA (510(k), K242683) with a decision date of 2025-03-18. Review panel: Radiology.
| FDA submission number | K242683 |
|---|---|
| Pathway | 510(k) |
| Company | Quibim S.L. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-03-18 |
| Decision | Substantially Equivalent |
| Product code | QDQ |
| Classification | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| Device class | 2 |
| Regulation number | 892.2090 |
| Review time (calendar days) | 193 |
| Applicant country | ES |
Official FDA database record · FDA AI-enabled device list
More devices from Quibim S.L. · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.