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..

Clearance details

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

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