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FDA 510(k)

QP-Prostate® CAD

K-Number: K242683 · 2025-03-18

ApplicantQuibim S.L.
Decision Date2025-03-18
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QP-Prostate® CAD is a medical device manufactured by Quibim S.L.. It received FDA 510(k) clearance on 2025-03-18 under approval 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. It is manufactured by Quibim S.L.. The 510(k) number is K242683.

When was QP-Prostate® CAD approved by the FDA?

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

What company makes QP-Prostate® CAD?

QP-Prostate® CAD is manufactured by Quibim S.L..

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

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

Other Devices by Quibim S.L.

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

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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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