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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 K260584
Device Name BoneMRI
Applicant
Mriguidance B.V.
Maliesingel 23
Utrecht,  NL 3581 BG
Applicant Contact Marijn van Stralen
Correspondent
Avania CRO Canada
250 Carlaw Ave., Suite 108
Toronto,  CA M4M 3L1
Correspondent Contact Sam Engelman
Regulation Number892.2050
Classification Product Code
QIH  
Date Received02/20/2026
Decision Date 08/21/2026
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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