EchoPAC Software Only, EchoPAC Plug-in

Automated Radiological Image Processing Software

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 IDK220940
510k NumberK220940
Device Name:EchoPAC Software Only, EchoPAC Plug-in
ClassificationAutomated Radiological Image Processing Software
Applicant GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC 9900 W. Innovation Drive Wauwatosa,  WI  53226
ContactTracey Ortiz
CorrespondentLee Bush
GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC 9900 W. Innovation Drive Wauwatosa,  WI  53226
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-31
Decision Date2022-07-22

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