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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
510(k) Number K253963
Device Name Cubresa BrainPET
Applicant
Cubresa, Inc.
136 Market Ave.
Suite 800
Winnipeg,  CA R3B 0P4
Applicant Contact Lisa Bako
Correspondent
Device Pathways, LLC
5054 Merrimac Ln. N
Plymouth,  MN  55446
Correspondent Contact Sanjay Shah
Regulation Number892.1200
Classification Product Code
OUO  
Subsequent Product Codes
KPS   LNH   MOS  
Date Received12/11/2025
Decision Date 07/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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