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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer Assisted Detection/Diagnosis Software For Fracture
510(k) Number K260378
Device Name Rayvolve
Applicant
AZmed
10 Rue D'Uzès
Paris,  FR
Applicant Contact Shanni Zeitoun
Correspondent
AZmed
10 Rue D'Uzès
Paris,  FR
Correspondent Contact Shanni Zeitoun
Classification Product Code
QBS  
Date Received02/05/2026
Decision Date 05/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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