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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
Recalls CDRH Recalls
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