Ultimax-i, DREX-UI80 V1.60

Interventional Fluoroscopic X-ray System

Toshiba Medical Systems Corporation

The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Ultimax-i, Drex-ui80 V1.60.

Pre-market Notification Details

Device IDK170832
510k NumberK170832
Device Name:Ultimax-i, DREX-UI80 V1.60
ClassificationInterventional Fluoroscopic X-ray System
Applicant Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-shi,  JP 324-8550
ContactPaul Biggins
CorrespondentPaul Biggins
Toshiba America Medical Systems, Inc. 2441 Michelle Drive Tustin,  CA  92780
Product CodeOWB  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-20
Decision Date2017-07-21
Summary:summary

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