FDA 510(k)

QP-Brain®

K-Number: K232231 · 2023-12-13

Decision Date2023-12-13

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

QP-Brain® 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 2023-12-13 under 510(k) 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. The listed applicant is Quibim S.L.. The 510(k) number is K232231.

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

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

Who is the listed applicant for QP-Brain®?

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-Brain®?

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

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.

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

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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.