Trinias

Interventional Fluoroscopic X-ray System

Shimadzu Corporation Medical Systems Division

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

Pre-market Notification Details

Device IDK221922
510k NumberK221922
Device Name:Trinias
ClassificationInterventional Fluoroscopic X-ray System
Applicant Shimadzu Corporation Medical Systems Division 1, Nishinokyo-Kuwabaracho, Nakagyo-ku Kyoto,  JP 604-8511
ContactKoichi Kataoka
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeOWB  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-01
Decision Date2022-07-28

Trademark Results [Trinias]

Mark Image

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

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