TC+ SYSTEM (TILTING C-ARM SYSTEM)

Interventional Fluoroscopic X-ray System

GE MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Tc+ System (tilting C-arm System).

Pre-market Notification Details

Device IDK936180
510k NumberK936180
Device Name:TC+ SYSTEM (TILTING C-ARM SYSTEM)
ClassificationInterventional Fluoroscopic X-ray System
Applicant GE MEDICAL SYSTEMS 3000 N GRANDVIEW BLVD. W-709 Waukesha,  WI  53188
Product CodeOWB  
Subsequent Product CodeJAA
Subsequent Product CodeOXO
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-27
Decision Date1994-03-16

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