K242683
- 510(k) number
- K242683
- Device name
- QP-Prostate® CAD
- Applicant
- Quibim S.L. ES
- Product code
- QDQ — Radiological Computer Assisted Detection/Diagnosis S
- Decision date
- 2025-03-18
- Date received
- 2024-09-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K242683.pdf
Official FDA record: K242683
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.