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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
Regulation Number892.2090
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
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