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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 K262390
Device Name BoneXpert
Applicant
Visiana
Fremtidsvej 1
Horsholm,  DK DK-2970
Applicant Contact Hans Henrik Thodberg
Correspondent
Hogan Lovells Cadwalader US LLP
1735 Market St., Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number892.2050
Classification Product Code
QIH  
Date Received07/13/2026
Decision Date 09/22/2026
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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