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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Medical Image
510(k) Number K243831
Device Name Rayvolve LN
Applicant
AZmed
10 Rue d'Uzès
Paris,  FR 75002
Applicant Contact Christelle Baille
Correspondent
AZmed
10 Rue d'Uzès
Paris,  FR 75002
Correspondent Contact Christelle Baille
Regulation Number892.2070
Classification Product Code
MYN  
Date Received12/13/2024
Decision Date 03/26/2025
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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