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FDA 510(k)

QP-Brain®

K-Number: K232231 · 2023-12-13

ApplicantQuibim S.L.
Decision Date2023-12-13
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QP-Brain® is a medical device manufactured by Quibim S.L.. It received FDA 510(k) clearance on 2023-12-13 under approval number K232231. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QP-Brain®?

QP-Brain® is a medical device that received FDA 510(k) clearance on 2023-12-13. It is manufactured by Quibim S.L.. The 510(k) number is K232231.

When was QP-Brain® approved by the FDA?

QP-Brain® received FDA 510(k) clearance on 2023-12-13, under approval number K232231.

What company makes QP-Brain®?

QP-Brain® is manufactured by Quibim S.L..

What is the FDA product code for QP-Brain®?

The FDA product code for QP-Brain® is QIH.

Other Devices by Quibim S.L.

K203582QUIBIM Precision Prostate (qp-Prostate) K242683QP-Prostate® CAD

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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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