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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K201825
Device Name MiniCAT 2D
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 Number892.1680
Classification Product Code
KPR  
Date Received07/02/2020
Decision Date 11/20/2020
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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