TRINIAS

Interventional Fluoroscopic X-ray System

Shimadzu Corporation

The following data is part of a premarket notification filed by Shimadzu Corporation with the FDA for Trinias.

Pre-market Notification Details

• Device ID: K123508
• 510k Number: K123508
• Device Name: TRINIAS
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: Shimadzu Corporation 1 Nishinokyo-Kuwabaracho Nakagyo-ku Kyoto, JP 604-8511
• Contact: Toshio Kadowaki
• Correspondent: Jeffrey Seiler; Shimadzu Medical Systems 20101 South Vermont Avenue Torrance, CA 90502 -1328
• Product Code: OWB
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-11-13
• Decision Date: 2014-02-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04540217058792	K123508	000
04540217057917	K123508	000
04540217057900	K123508	000
04540217049080	K123508	000
04540217049073	K123508	000
04540217049066	K123508	000
04540217048939	K123508	000
04540217048922	K123508	000
04540217048915	K123508	000
04540217064762	K123508	000
04540217064021	K123508	000
04540217061136	K123508	000
04540217061099	K123508	000
04540217061006	K123508	000
04540217059607	K123508	000
04540217057924	K123508	000
04540217058020	K123508	000
04540217058037	K123508	000
04540217058754	K123508	000
04540217058716	K123508	000
04540217058709	K123508	000
04540217058631	K123508	000
04540217058624	K123508	000
04540217058365	K123508	000
04540217058327	K123508	000
04540217058280	K123508	000
04540217058273	K123508	000
04540217058266	K123508	000
04540217058167	K123508	000
04540217058150	K123508	000
04540217058143	K123508	000
04540217058044	K123508	000
04540217059553	K123508	000