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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 K212040
Device Name RI.HIP MODELER
Applicant
Blue Belt Technologies, Inc.
2905 Northwest Blvd.
Suite 40
Plymouth,  MN  55441
Applicant Contact Michael Gosha
Correspondent
Blue Belt Technologies, Inc.
2905 Northwest Blvd.
Suite 40
Plymouth,  MN  55441
Correspondent Contact Michael Gosha
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/30/2021
Decision Date 03/11/2022
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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