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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 K240845
Device Name Rayvolve
Applicant
AZmed SAS
6 rue Léonard de Vinci
Laval,  FR 5300
Applicant Contact Christelle Baille
Correspondent
AZmed SAS
6 rue Léonard de Vinci
Laval,  FR 53000
Correspondent Contact Christelle Baille
Classification Product Code
QBS  
Date Received03/27/2024
Decision Date 07/17/2024
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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