FDA 510(k) Applications Submitted by Tracey Ortiz

FDA 510(k) Number Submission Date Device Name Applicant
K161588 06/08/2016 Vscan Extend GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC
K160078 01/14/2016 Vivid T8 GE Medical Systems Ultrasound and Primary Care Diagnotics, L
K200138 01/21/2020 Versana Premier GE Medical Systems Ultrasound and
K200119 01/21/2020 LOGIQ E10s GE Medical Systems Ultrasound and Primary Care Diagnostics,
K200158 01/22/2020 LOGIQ E10 GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC
K110227 01/25/2011 OPTIMA CT660 GE MEDICAL SYSTEMS, LLC
K160162 01/27/2016 Voluson P6, Voluson P8 GE HEALTHCARE
K160184 01/27/2016 Voluson S6, Voluson S8, Voluson S10 GE HEALTHCARE
K160277 02/02/2016 LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 GE Medical Systems Ultrasound and Primary Care Diagnostics,
K210438 02/12/2021 Versana Premier GE Medical Systems Ultrasound and Primary Care Diagnostics,
K220446 02/16/2022 Versana Balance GE Medical Systems Ultrasound and Primary Care Diagnostics,
K200497 02/28/2020 Vivid S60N, Vivid S70N GE Medical Systems Ultrasound and Primary Care Diagnostics
K220619 03/03/2022 Vivid S60N, Vivid S70N GE Medical Systems Ultrasound and Primary Care Diagnostics,
K180599 03/07/2018 Venue GE Medical Systems Ultrasound and Primary Care Diagnostics,
K170714 03/09/2017 Venue GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
K200708 03/18/2020 Vivid iq GE Medical Systems Ultrasound and
K140693 03/19/2014 VSCAN WITH DUAL PROBE GE MEDICAL SYSYEMS ULTRASOUND & PRIMARY CARE DIAGN
K170823 03/20/2017 Vivid E80, Vivid E90, Vivid E95 GE Medical Systems Ultrasound and Primary Care Diagnostics
K200743 03/23/2020 Vivid E80/ Vivid E90/ Vivid E95 GE Medical Systems Ultrasound and
K170878 03/24/2017 Vivid S60N, Vivid S70N GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
K220882 03/25/2022 Vivid E80, Vivid E90, Vivid E95 GE Medical Systems Ultrasound and
K200852 03/31/2020 EchoPAC Software Only, EchoPAC Plug-In GE Medical Systems Ultrasound and Primary Care Diagnostics
K200851 03/31/2020 Vivid T8, Vivid T9 GE Medical Systems Ultrasound and Primary Care Diagnostics
K220940 03/31/2022 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
K161224 04/29/2016 LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
K161706 06/20/2016 Vivid iq GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS L
K181685 06/26/2018 Vivid E80, Vivid E90, Vivid E95 GE Medical Systems Ultrasound and Primary Care Diagnostics,
K181727 06/29/2018 Vivid iq 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
K181934 07/19/2018 Vivid T8, Vivid T9 GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
K202035 07/23/2020 Vscan Air GE Medical Systems Ultrasound and Primary Care Diagnostics,
K202132 07/31/2020 Venue GE Medical Systems Ultrasound and Primary Care Diagnostics,
K202233 08/07/2020 Venue Go GE Medical Systems Ultrasound and Primary Care Diagnostics,
K182277 08/22/2018 Versana Premier GE Medical Systems Ultrasound and Primary Care Diagnostics,
K142472 09/03/2014 Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems GE Healthcare
K182450 09/07/2018 Vivid S60N, Vivid S70N 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
K082761 09/22/2008 GE LIGHTSPEED 7.2 CT SCANNER SYSTEM GE MEDICAL SYSTEMS, LLC
K152758 09/24/2015 Venue 50 GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
K182750 09/28/2018 4D View GE Medical Systems Ultrasound and Primary Care Diagnostics,
K162743 09/30/2016 ViewPoint 6 GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
K192917 10/15/2019 ViewPoint 6 GE Medical Systems Ultrasound and
K153037 10/19/2015 LOGIQ V1/ LOGIQ V2 GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC
K203137 10/20/2020 Venue Fit GE Medical Systems Ultrasound and Primary Care Diagnostics,
K173341 10/24/2017 Vivid E80, Vivid E90, Vivid E95 GE Medical Systems
K173456 11/07/2017 ViewPoint 6 GE Medical Systems Ultrasound and Primary
K093581 11/18/2009 DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS GE MEDICAL SYSTEMS, LLC
K183362 12/04/2018 Venue GO GE Medical Systems Ultrasound and Primary Care Diagnostics
K203677 12/17/2020 ViewPoint 6 GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC


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