FDA 510(k)

QP-Prostate® CAD

K-Number: K242683 · 2025-03-18

Decision Date2025-03-18

Product CodeQDQ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

QP-Prostate® CAD is the device name listed in this FDA 510(k) record. The listed applicant is Quibim S.L.. It received FDA 510(k) clearance on 2025-03-18 under 510(k) number K242683. 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 QP-Prostate® CAD?

QP-Prostate® CAD is a medical device that received FDA 510(k) clearance on 2025-03-18. The listed applicant is Quibim S.L.. The 510(k) number is K242683.

When did QP-Prostate® CAD receive FDA 510(k) clearance?

QP-Prostate® CAD received FDA 510(k) clearance on 2025-03-18, under 510(k) number K242683.

Who is the listed applicant for QP-Prostate® CAD?

The FDA 510(k) record lists Quibim S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QP-Prostate® CAD?

The FDA product code for QP-Prostate® CAD is QDQ.

Other records listing Quibim S.L. 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.

K232231QP-Brain®K203582QUIBIM Precision Prostate (qp-Prostate)

Related Devices (Code: QDQ)

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)Therapixel K253825Saige-DxDeepHealth, Inc.K253682DeepHealth ProstateAIQuantib B.V.

Official Source

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