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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 K252708
Device Name Relu Cloud
Applicant
Relu BV
Kolonel Begaultlaan 1a/51
Leuven,  BE 3012
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 Received08/27/2025
Decision Date 04/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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