INFX-8000V WITH

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.

Pre-market Notification Details

Device IDK120073
510k NumberK120073
Device Name:INFX-8000V WITH
ClassificationInterventional Fluoroscopic X-ray System
Applicant TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin,  CA  92780
ContactPaul Biggines
CorrespondentPaul Biggines
TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin,  CA  92780
Product CodeOWB  
Subsequent Product CodeIZI
Subsequent Product CodeJAA
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-10
Decision Date2012-01-26
Summary:summary

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