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 IDK203535
510k NumberK203535
Device Name:Trinias
ClassificationInterventional Fluoroscopic X-ray System
Applicant Shimadzu Corporation Medical Systems 1, Nishinokyo-Kuwabaracho, Nakagyo-ku Kyoto City,  JP 604-8511
ContactShigeru Naganishi
CorrespondentDaniel Kamm
Shimadzu Corporation Medical Systems 1, Nishinokyo-Kuwabaracho, Nakagyo-ku Kyoto City,  JP 604-8511
Product CodeOWB  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-03
Decision Date2021-04-28

Trademark Results [Trinias]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRINIAS
TRINIAS
86707621 4972141 Live/Registered
SHIMADZU CORPORATION
2015-07-28

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.