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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K250416
Device Name GBrain MRI
Applicant
Galileo Cds, Inc.
7000 N. Mopac Expressway Suite 200 
Austin,  TX  78731
Applicant Contact Abhijeet Pradhan
Correspondent
Innolitics, LLC
1101 W. 34th St.
#550
Austin,  TX  78705
Correspondent Contact Mary Vater
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received02/13/2025
Decision Date 04/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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