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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K243292
Device Name brAIn™ Shoulder Positioning
Applicant
Avatar Medical
11 Rue De Lourmel
Paris,  FR 75015
Applicant Contact Adeline Francois
Correspondent
Avatar Medical
11 Rue De Lourmel
Paris,  FR 75015
Correspondent Contact Adeline Francois
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
QIH  
Date Received10/18/2024
Decision Date 03/20/2025
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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