INFX-8000V With Wireless Footswitch

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 Infx-8000v With Wireless Footswitch.

Pre-market Notification Details

Device IDK143225
510k NumberK143225
Device Name:INFX-8000V With Wireless Footswitch
ClassificationInterventional Fluoroscopic X-ray System
Applicant TOSHIBA MEDICAL SYSTEMS CORPORATION 1385 SHIMOISHIGAMI Otawara-shi, Tochigi-ken,  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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-10
Decision Date2015-01-09
Summary:summary

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