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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K260321
Device Name HipGuide (V 1.0.0.0)
Applicant
Orthopedic Driven Imaging, LLC
4424 NW 13th St., Suite B-6
Gainesville,  FL  32609
Applicant Contact Michael McCaig
Correspondent
Orthopedic Driven Imaging, LLC
4424 NW 13th St., Suite B-6
Gainesville,  FL  32609
Correspondent Contact Michael McCaig
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/30/2026
Decision Date 05/08/2026
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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