K253682
- 510(k) number
- K253682
- Device name
- DeepHealth ProstateAI
- Applicant
- Quantib B.V. NL
- Product code
- QDQ — Radiological Computer Assisted Detection/Diagnosis S
- Decision date
- 2026-04-29
- Date received
- 2025-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253682.pdf
Official FDA record: K253682
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.