Cubresa BrainPET— 510(k) K253963

Name: FDA 510(k) clearance K253963
Creator: U.S. Food and Drug Administration
Published: 2026-07-17

Substantially Equivalent

Cubresa, Inc.

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

Summary

Cubresa's BrainPET is filed under OUO, tomographic imagers combining emission computed tomography with nuclear magnetic resonance. The record doesn't give specs or list components.

Class II, 21 CFR 892.1200. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).

Cubresa filed from Winnipeg, Canada. Review took 218 calendar days (December 11, 2025 to July 17, 2026).

Clearance details

Applicant: Cubresa, Inc.
Product code: Product 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

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