ViewPoint 6

System, Image Processing, Radiological

GE Medical Systems Ultrasound And

The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And with the FDA for Viewpoint 6.

Pre-market Notification Details

Device IDK192917
510k NumberK192917
Device Name:ViewPoint 6
ClassificationSystem, Image Processing, Radiological
Applicant GE Medical Systems Ultrasound And Primary Care Diagnostics LLC 9900 W. Innovation Drive Wauwatosa,  WI  53226
ContactTracey Ortiz
CorrespondentTracey Ortiz
GE Medical Systems Ultrasound And Primary Care Diagnostics LLC 9900 W. Innovation Drive Wauwatosa,  WI  53226
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-15
Decision Date2020-01-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682171953 K192917 000

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