FDA 510(k)

QUIBIM Precision Prostate (qp-Prostate)

K-Number: K203582 · 2021-02-04

Decision Date2021-02-04

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

QUIBIM Precision Prostate (qp-Prostate) is a medical device manufactured by Quibim S.L.. It received FDA 510(k) clearance on 2021-02-04 under approval number K203582. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIBIM Precision Prostate (qp-Prostate)?

QUIBIM Precision Prostate (qp-Prostate) is a medical device that received FDA 510(k) clearance on 2021-02-04. It is manufactured by Quibim S.L.. The 510(k) number is K203582.

When was QUIBIM Precision Prostate (qp-Prostate) approved by the FDA?

QUIBIM Precision Prostate (qp-Prostate) received FDA 510(k) clearance on 2021-02-04, under approval number K203582.

What company makes QUIBIM Precision Prostate (qp-Prostate)?

QUIBIM Precision Prostate (qp-Prostate) is manufactured by Quibim S.L..

What is the FDA product code for QUIBIM Precision Prostate (qp-Prostate)?

The FDA product code for QUIBIM Precision Prostate (qp-Prostate) is LLZ.

Related Clinical Trials

NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING

Other Devices by Quibim S.L.

K232231QP-Brain® K242683QP-Prostate® CAD

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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.