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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 K222035
Device Name Avatar Medical Software V1
Applicant
Avatar Medical
11 rue de Lourmel
Paris,  FR 75015
Applicant Contact Elodie Brient-Litzler
Correspondent
COSM
45 Bartlett St.
San Francisco,  CA  94110
Correspondent Contact Rory Carrillo
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/11/2022
Decision Date 05/24/2023
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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