Cubresa BrainPET— 510(k) K253963

Substantially Equivalent

Cubresa, Inc.

FDA 510(k) clearance K253963 for Cubresa BrainPET, Substantially Equivalent on 2026-07-17. Applicant: Cubresa, Inc.. Device class: 2.

Clearance details

Applicant: Cubresa, Inc.
Product code: Code OUO
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2025-12-11
Decision date: 2026-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winnipeg, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code OUO

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K213709 — SIGNA PET/MR2022-01-20
K200213 — Biograph mMR with syngo MR E11P-AP01 system software2020-05-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.