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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 the device name listed in this FDA 510(k) record. The listed applicant is Quantib B.V.. It received FDA 510(k) clearance on 2026-04-29 under 510(k) 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. The listed applicant is Quantib B.V.. The 510(k) number is K253682.

When did DeepHealth ProstateAI receive FDA 510(k) clearance?

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

Who is the listed applicant for DeepHealth ProstateAI?

The FDA 510(k) record lists Quantib B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DeepHealth ProstateAI?

The FDA product code for DeepHealth ProstateAI is QDQ.

Other records listing Quantib B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251527Brain WMHK230772Quantib ProstateK221106Quantib ProstateK213737Quantib NDK202501Quantib ProstateK200899Quantib AI Node

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Related Devices (Code: QDQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260898Transpara (2.1.0)Screenpoint Medical B.V.K260086CadAI-B DxBeamWorks, Inc.K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.K260714MammoScreen® (5)TherapixelK253825Saige-DxDeepHealth, Inc.K260320Lunit INSIGHT MMG (v1.1.10)Lunit, Inc.

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.

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