Universal Viewer

System, Image Processing, Radiological

GE Healthcare

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

Pre-market Notification Details

Device IDK211312
510k NumberK211312
Device Name:Universal Viewer
ClassificationSystem, Image Processing, Radiological
Applicant GE Healthcare 500 W. Monroe Street Chicago,  IL  60661 -3671
ContactJohn Braam
CorrespondentJohn Braam
GE Healthcare 500 W. Monroe Street Chicago,  IL  60661 -3671
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-30
Decision Date2021-05-21

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