GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM

System, X-ray, Tomography, Computed

GE MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Ge Lightspeed Rt16 / Lightspeed Xtra V2 Ct System (aka Ge Lightspeed Rt16 / Lightspeed Xtra Ct System.

Pre-market Notification Details

Device IDK082104
510k NumberK082104
Device Name:GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM
ClassificationSystem, X-ray, Tomography, Computed
Applicant GE MEDICAL SYSTEMS, INC. 3000 N. GRANDVIEW BLVD. W-706 Waukesha,  WI  53188
ContactSteven Kachelmeyer
CorrespondentJay Y Kogoma
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-07-25
Decision Date2008-09-02
Summary:summary

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