ADVANTAGE 4D OPTION

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 Advantage 4d Option.

Pre-market Notification Details

Device IDK032915
510k NumberK032915
Device Name:ADVANTAGE 4D OPTION
ClassificationSystem, X-ray, Tomography, Computed
Applicant GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. W-400 Waukesha,  WI  53188
ContactLarry A Kroger
CorrespondentJuergen Welte
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 Received2003-09-22
Decision Date2003-10-30
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.