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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
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