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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K262442
Device Name HipStudio Analysis
Applicant
Replasia BV
Interleuvenlaan 62 Box 26
Leuven,  BE 3001
Applicant Contact Tim Van Cleynenbreugel
Correspondent
Aucto BV
Brusselsesteenweg 560
Meerbeke,  BE 9402
Correspondent Contact Carl Van Lierde
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/16/2026
Decision Date 09/22/2026
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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