CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT

System, Image Processing, Radiological

GE HEALTHCARE

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Centricity Universal Viewer Zero Footprint Client.

Pre-market Notification Details

Device IDK131977
510k NumberK131977
Device Name:CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT
ClassificationSystem, Image Processing, Radiological
Applicant GE HEALTHCARE 540 W. NORTHWEST HIGHWAY Barrington,  IL  60010
ContactNicole Landreville
CorrespondentNicole Landreville
GE HEALTHCARE 540 W. NORTHWEST HIGHWAY Barrington,  IL  60010
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-28
Decision Date2013-09-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682102988 K131977 000

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