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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 K210257
Device Name Xoran Workstation, Model 10050
Applicant
Xoran Technologies, LLC
5210 S. State Rd.
Ann Arbor,  MI  48108
Applicant Contact Mark McGarrow
Correspondent
Xoran Technologies, LLC
5210 S. State Rd.
Ann Arbor,  MI  48108
Correspondent Contact Mark McGarrow
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/01/2021
Decision Date 05/20/2021
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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