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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 K242171
Device Name TechCare Trauma
Applicant
Milvue
29 Rue Du Faubourg Saint Jacques
Paris,  FR 75014
Applicant Contact Mathieu Quintin
Correspondent
Hogan Lovells US LLP
555 Thirteenth St. NW
Washington,  DC 
Correspondent Contact John Smith
Classification Product Code
QBS  
Date Received07/24/2024
Decision Date 01/17/2025
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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