510(k) K253682— DeepHealth ProstateAI

Substantially Equivalent

Quantib B.V.

Clearance details

Applicant: Quantib B.V.
Product code: Code QDQ
Advisory panel: Radiology
Date received: 2025-11-21
Decision date: 2026-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rotterdam, NL

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.