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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, Mobile
510(k) Number K143537
Device Name Sirius Starmobile tiara
Applicant
Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg,  OH  44087
Applicant Contact DOUG THISTLEWAITE
Correspondent
Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg,  OH  44087
Correspondent Contact DOUG THISTLEWAITE
Regulation Number892.1720
Classification Product Code
IZL  
Date Received12/15/2014
Decision Date 03/06/2015
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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