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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 Prioritization Software For Lesions
510(k) Number K243808
Device Name Rayvolve PTX-PE
Applicant
Azmed
10 Rue D'Uzès
Paris,  FR 75002
Applicant Contact Anthony Joseph
Correspondent
Azmed
10 Rue D'Uzès
Paris,  FR 75002
Correspondent Contact Anthony Joseph
Regulation Number892.2080
Classification Product Code
QFM  
Date Received12/11/2024
Decision Date 03/21/2025
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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