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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 K233925
Device Name Relu Creator
Applicant
Relu BV
Kapeldreef 60
Leuven,  BE 3001
Applicant Contact Holger Willems
Correspondent
Prime Path Medtech
1321 Upland Dr.
Suite 6792
Houston,  TX  77043
Correspondent Contact Breanne Butler
Regulation Number892.2050
Classification Product Code
QIH  
Date Received12/13/2023
Decision Date 06/13/2024
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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