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

FDA 510(k) Number Submission Date Device Name Applicant
K242168 07/24/2024 Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 GE Medical Systems Ultrasound and Primary care Diagnostics
K250543 02/24/2025 VolusonÖ Performance 16; VolusonÖ Performance 18 GE Medical Systems Ultrasound and Primary care Diagnostics
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
K243620 11/22/2024 Vivid iq GE Medical Systems Ultrasound and Primary Care Diagnostics
K243628 11/25/2024 Vivid T9/Vivid T8 GE Medical Systems Ultrasound and Primary Care Diagnostics
K240053 01/08/2024 Venue Go GE Medical Systems Ultrasound and Primary Care Diagnostics
K240111 01/16/2024 Venue GE Medical Systems Ultrasound and Primary Care Diagnostics
K240206 01/25/2024 Venue Sprint GE Medical Systems Ultrasound and Primary Care Diagnostics
K234106 12/26/2023 Venue Fit GE Medical Systems Ultrasound and Primary Care Diagnostics
K250087 01/14/2025 Vscan Air GE Medical Systems Ultrasound and Primary Care Diagnostics
K220800 03/18/2022 Venue Go GE Medical Systems Ultrasound and Primary Care Diagnostics
K251169 04/15/2025 Vivid Pioneer GE Medical Systems Ultrasound and Primary Care Diagnostics
K251342 04/30/2025 EchoPAC Software Only / EchoPAC Plug-in GE Medical Systems Ultrasound and Primary Care Diagnostics
K242005 07/09/2024 Versana Premier; Versana Premier Lotus; LOGIQ F 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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