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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K242166
Device Name TribusConnect
Applicant
Tribusmed Beheer BV
Oude Vest 9
Breda,  NL 4811HR
Applicant Contact Johan Vogelaar
Correspondent
Tribusmed Beheer BV
Oude Vest 9
Breda,  NL 4811HR
Correspondent Contact Johan Vogelaar
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received07/24/2024
Decision Date 03/31/2025
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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