VOLUME VIEWER PLUS

System, X-ray, Tomography, Computed

GENERAL ELECTRIC MEDICAL SYSTEMS

The following data is part of a premarket notification filed by General Electric Medical Systems with the FDA for Volume Viewer Plus.

Pre-market Notification Details

Device IDK041521
510k NumberK041521
Device Name:VOLUME VIEWER PLUS
ClassificationSystem, X-ray, Tomography, Computed
Applicant GENERAL ELECTRIC MEDICAL SYSTEMS 3000 N. GRANDVIEW BLVD. Waukesha,  WI  53188
ContactLarry Krueger
CorrespondentTamas Borsai
TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton,  CT  06470
Product CodeJAK  
Subsequent Product CodeLLZ
Subsequent Product CodeLNH
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-06-08
Decision Date2004-06-22
Summary:summary

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