FDA 510(k) Applications Submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics

FDA 510(k) Number Submission Date Device Name Applicant
K201828 07/02/2020 Voluson SWIFT, Voluson SWIFT+ GE Medical Systems Ultrasound and Primary Care Diagnostics
K152309 08/14/2015 LOGIQ E9, LOGIQ E9 XDClear 2.0 GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
K203114 10/15/2020 LOGIQ P10, LOGIQ P9, LOGIQ P8 GE Medical Systems Ultrasound and Primary Care Diagnostics
K231301 05/05/2023 Vscan Air GE Medical Systems Ultrasound and Primary Care Diagnostics
K220800 03/18/2022 Venue Go GE Medical Systems Ultrasound and Primary Care Diagnostics
K170847 03/20/2017 EchoPAC Software Only, EchoPAC Plug-in GE Medical Systems Ultrasound and Primary Care Diagnostics
K200497 02/28/2020 Vivid S60N, Vivid S70N GE Medical Systems Ultrasound and Primary Care Diagnostics
K170823 03/20/2017 Vivid E80, Vivid E90, Vivid E95 GE Medical Systems Ultrasound and Primary Care Diagnostics
K200851 03/31/2020 Vivid T8, Vivid T9 GE Medical Systems Ultrasound and Primary Care Diagnostics
K200852 03/31/2020 EchoPAC Software Only, EchoPAC Plug-In GE Medical Systems Ultrasound and Primary Care Diagnostics
K180995 04/16/2018 Vscan Extend GE Medical Systems Ultrasound and Primary Care Diagnostics
K200998 04/16/2020 Versana Active GE Medical Systems Ultrasound and Primary Care Diagnostics
K151028 04/17/2015 LOGIQ e GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
K211216 04/23/2021 Vivid S60N / Vivid S70N GE Medical Systems Ultrasound and Primary Care Diagnostics
K191792 07/03/2019 Versana Balance GE Medical Systems Ultrasound and Primary Care Diagnostics
K191798 07/03/2019 Versana Active GE Medical Systems Ultrasound and Primary Care Diagnostics
K202658 09/14/2020 Vivid E80/ Vivid E90/ Vivid E95 GE Medical Systems Ultrasound and Primary Care Diagnostics
K152758 09/24/2015 Venue 50 GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
K162743 09/30/2016 ViewPoint 6 GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
K183362 12/04/2018 Venue GO GE Medical Systems Ultrasound and Primary Care Diagnostics


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