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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
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