ADVANTAGE WINDOWS CT/PET FUSION

System, Image Processing, Radiological

GE MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Advantage Windows Ct/pet Fusion.

Pre-market Notification Details

Device IDK010336
510k NumberK010336
Device Name:ADVANTAGE WINDOWS CT/PET FUSION
ClassificationSystem, Image Processing, Radiological
Applicant GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee,  WI  53201
ContactLarry A Kroger
CorrespondentReiner Krumme
TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton,  CT  06470
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2001-02-05
Decision Date2001-02-16

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