EchoPAC Software Only, EchoPAC Plug-In

System, Image Processing, Radiological

GE Medical Systems Ultrasound And Primary Care Diagnostics

The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary Care Diagnostics with the FDA for Echopac Software Only, Echopac Plug-in.

Pre-market Notification Details

Device IDK200852
510k NumberK200852
Device Name:EchoPAC Software Only, EchoPAC Plug-In
ClassificationSystem, Image Processing, Radiological
Applicant GE Medical Systems Ultrasound And Primary Care Diagnostics 9900 Innovation Drive Wauwatosa,  WI  53226
ContactTracey Ortiz
CorrespondentTracey Ortiz
GE Medical Systems Ultrasound And Primary Care Diagnostics 9900 Innovation Drive Wauwatosa,  WI  53226
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-31
Decision Date2020-09-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682146876 K200852 000
00840682146876 K200852 000
00840682146883 K200852 000
00840682146876 K200852 000
00840682146883 K200852 000
00840682146876 K200852 000
00840682146883 K200852 000
00840682146883 K200852 000
00840682146883 K200852 000
00840682146883 K200852 000
00840682146883 K200852 000
00840682146883 K200852 000
00840682146883 K200852 000
00840682146883 K200852 000
00840682146876 K200852 000
00840682146876 K200852 000
00840682146876 K200852 000
00840682146876 K200852 000
00840682146876 K200852 000
00840682146876 K200852 000
00840682146876 K200852 000
00840682146876 K200852 000
00840682146883 K200852 000
00840682146876 K200852 000
00840682146883 K200852 000
00840682146876 K200852 000
00840682146883 K200852 000
00840682146883 K200852 000

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