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.
Summary
DeepHealth ProstateAI comes from Quantib B.V. and is filed under product code QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer). The record doesn't describe the software beyond its name and that code name.
Class II, 21 CFR 892.2090. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Quantib filed from Rotterdam, the Netherlands. The decision came 159 calendar days after FDA received it (November 21, 2025 to April 29, 2026).
Clearance details
- Applicant
- Quantib B.V.
- Product code
- Product 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
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