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FDA 510(k)

Cubresa BrainPET

K-Number: K253963 · 2026-07-17

ApplicantCubresa, Inc.
Decision Date2026-07-17
Product CodeOUO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Cubresa BrainPET is the device name listed in this FDA 510(k) record. The listed applicant is Cubresa, Inc.. It received FDA 510(k) clearance on 2026-07-17 under 510(k) number K253963. The device is classified under product code OUO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cubresa BrainPET?

Cubresa BrainPET is a medical device that received FDA 510(k) clearance on 2026-07-17. The listed applicant is Cubresa, Inc.. The 510(k) number is K253963.

When did Cubresa BrainPET receive FDA 510(k) clearance?

Cubresa BrainPET received FDA 510(k) clearance on 2026-07-17, under 510(k) number K253963.

Who is the listed applicant for Cubresa BrainPET?

The FDA 510(k) record lists Cubresa, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cubresa BrainPET?

The FDA product code for Cubresa BrainPET is OUO.

Related Devices (Code: OUO)

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.

K253023BIOGRAPH OneSiemens Healthineers AGK234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.K213709SIGNA PET/MRGe Medical Systems, LLCK200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.

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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