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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 K220164
Device Name Rayvolve
Applicant
Azmed Sas
6 Rue Leonard De Vinci
Laval,  FR 53000
Applicant Contact Patricia Massako
Correspondent
Azmed Sas
6 Rue Leonard De Vinci
Laval,  FR 53000
Correspondent Contact Patricia Massako
Classification Product Code
QBS  
Date Received01/20/2022
Decision Date 06/02/2022
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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