GE LIGHTSPEED XTRA CT SCANNER SYSTEM

System, X-ray, Tomography, Computed

GE MEDICAL SYSTEMS, LLC

The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Ge Lightspeed Xtra Ct Scanner System.

Pre-market Notification Details

Device IDK060052
510k NumberK060052
Device Name:GE LIGHTSPEED XTRA CT SCANNER SYSTEM
ClassificationSystem, X-ray, Tomography, Computed
Applicant GE MEDICAL SYSTEMS, LLC 3000 N. GRANDVIEW BLVD. Waukesha,  WI  53188
ContactGlen E Sabin
CorrespondentTamas Borsai
TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton,  CT  06470
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-01-06
Decision Date2006-04-19
Summary:summary

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