Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DeepHealth ProstateAI

K-Number: K253682 · 2026-04-29

ApplicantQuantib B.V.
Decision Date2026-04-29
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DeepHealth ProstateAI is a medical device manufactured by Quantib B.V.. It received FDA 510(k) clearance on 2026-04-29 under approval number K253682. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DeepHealth ProstateAI?

DeepHealth ProstateAI is a medical device that received FDA 510(k) clearance on 2026-04-29. It is manufactured by Quantib B.V.. The 510(k) number is K253682.

When was DeepHealth ProstateAI approved by the FDA?

DeepHealth ProstateAI received FDA 510(k) clearance on 2026-04-29, under approval number K253682.

What company makes DeepHealth ProstateAI?

DeepHealth ProstateAI is manufactured by Quantib B.V..

What is the FDA product code for DeepHealth ProstateAI?

The FDA product code for DeepHealth ProstateAI is QDQ.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑