Trinias

Interventional Fluoroscopic X-ray System

Shimadzu Corporation Medical Systems

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

Pre-market Notification Details

• Device ID: K203535
• 510k Number: K203535
• Device Name: Trinias
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: Shimadzu Corporation Medical Systems 1, Nishinokyo-Kuwabaracho, Nakagyo-ku Kyoto City, JP 604-8511
• Contact: Shigeru Naganishi
• Correspondent: Daniel Kamm; Shimadzu Corporation Medical Systems 1, Nishinokyo-Kuwabaracho, Nakagyo-ku Kyoto City, JP 604-8511
• Product Code: OWB
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-12-03
• Decision Date: 2021-04-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04540217068807	K203535	000
04540217066872	K203535	000
04540217066889	K203535	000
04540217066896	K203535	000
04540217066902	K203535	000
04540217066919	K203535	000
04540217066926	K203535	000
04540217066933	K203535	000
04540217066940	K203535	000
04540217067015	K203535	000
04540217067022	K203535	000
04540217067039	K203535	000
04540217066865	K203535	000
04540217064953	K203535	000
04540217068937	K203535	000
04540217068944	K203535	000
04540217068951	K203535	000
04540217064878	K203535	000
04540217064885	K203535	000
04540217064892	K203535	000
04540217064908	K203535	000
04540217064915	K203535	000
04540217064922	K203535	000
04540217064939	K203535	000
04540217064946	K203535	000
04540217067046	K203535	000
04540217067053	K203535	000
04540217062928	K203535	000
04540217062973	K203535	000
04540217062980	K203535	000
04540217063031	K203535	000
04540217063048	K203535	000
04540217063093	K203535	000
04540217063109	K203535	000
04540217063154	K203535	000
04540217063161	K203535	000
04540217063192	K203535	000
04540217063222	K203535	000
04540217062911	K203535	000
04540217062867	K203535	000
04540217067060	K203535	000
04540217067077	K203535	000
04540217067084	K203535	000
04540217067091	K203535	000
04540217067107	K203535	000
04540217067114	K203535	000
04540217067121	K203535	000
04540217067138	K203535	000
04540217067145	K203535	000
04540217067152	K203535	000
04540217062850	K203535	000
04540217063253	K203535	000