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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 K261378
Device Name Rayvolve AZchest
Applicant
AZmed
10 Rue D'Uzès
Paris,  FR 75002
Applicant Contact Victor DE POLLI
Correspondent
AZmed
10 Rue D'Uzès
Paris,  FR 75002
Correspondent Contact Victor DE POLLI
Classification Product Code
QBS  
Date Received04/27/2026
Decision Date 08/28/2026
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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