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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 K252091
Device Name Surgical Reality Viewer
Applicant
Medicalvr B.V.
Markkaweg 2
Nieuw-Vennep,  NL 2153NB
Applicant Contact Chris Hordijk
Correspondent
Medqair Services B.V.
Rooseveltlaan 56-2
Amsterdam,  NL 1078NL
Correspondent Contact Leon Doorn
Regulation Number892.2050
Classification Product Code
QIH  
Date Received07/03/2025
Decision Date 01/29/2026
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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