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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, Tomography, Computed
510(k) Number K163528
Device Name HITACHI Supria Whole-body X-ray CT System Phase 3
Applicant
Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg,  OH  44087
Applicant Contact Doug Thistlethwaite
Correspondent
Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg,  OH  44087
Correspondent Contact Doug Thistlethwaite
Regulation Number892.1750
Classification Product Code
JAK  
Date Received12/16/2016
Decision Date 03/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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