DeepHealth ProstateAI— 510(k) K253682
Substantially EquivalentQuantib B.V.
FDA 510(k) clearance K253682 for DeepHealth ProstateAI, Substantially Equivalent on 2026-04-29. Applicant: Quantib B.V.. Device class: 2.
Clearance details
- Applicant
- Quantib B.V.
- Product code
- Code QDQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2090
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rotterdam, NL
Recent devices under product code QDQ
view allMore clearances from Quantib B.V.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.