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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K123508
Device Name TRINIAS
Applicant
Shimadzu Corporation
1 Nishinokyo-Kuwabaracho Nakagyo-ku
Kyoto,  JP 604-8511
Applicant Contact Toshio Kadowaki
Correspondent
Shimadzu Medical Systems
20101 South Vermont Avenue
Torrance,  CA  90502 -1328
Correspondent Contact Jeffrey Seiler
Regulation Number892.1650
Classification Product Code
OWB  
Date Received11/13/2012
Decision Date 02/26/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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