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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 K260206
Device Name SkeletonPlanner
Applicant
UPlanner B.V. - Presurgeo
Nigtevechtseweg 94
Vreeland,  NL 3633XW
Applicant Contact Frans van Belle
Correspondent
Britton Medical Consultancy, LLC
19123 W. 60th Ln.
Golden,  CO  80403
Correspondent Contact Carrie Britton
Regulation Number892.2050
Classification Product Code
QIH  
Date Received01/23/2026
Decision Date 07/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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