FDA 510(k) Applications Submitted by SAMSUNG MEDISON CO., LTD.

FDA 510(k) Number Submission Date Device Name Applicant
K171070 04/10/2017 WS80A Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K163691 12/28/2016 HS70A Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K221599 06/02/2022 HS40 Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K231772 06/16/2023 V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K210713 03/10/2021 HM70 EVO Diagnostic Ultrasound System Samsung Medison CO., LTD.
K220975 04/04/2022 V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K221117 04/18/2022 RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K182632 09/24/2018 HS30 Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K173513 11/13/2017 WS80A Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K190444 02/25/2019 HERA I10 Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K200699 03/17/2020 HS70A Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K180883 04/04/2018 5D Viewer Samsung Medison Co., Ltd.
K171048 04/07/2017 RS80A Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K181336 05/21/2018 HS50 / HS60 Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K192030 07/30/2019 RS80 EVO Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K192319 08/26/2019 HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K182595 09/20/2018 HERA W10 Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K182932 10/22/2018 RS85 Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K173713 12/04/2017 HS70A Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K170493 02/17/2017 HS50 / HS60 Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K172129 07/14/2017 HS40 Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K210426 02/11/2021 HS40 Diagnostic Ultrasound System Samsung Medison CO., LTD.
K223387 11/07/2022 V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K220269 01/31/2022 HM70 EVO Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K150478 02/24/2015 A35 Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD.
K151663 06/19/2015 RS80A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD.
K161955 07/18/2016 5D Viewer SAMSUNG Medison Co., Ltd.
K152962 10/07/2015 HS70A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD.
K153529 12/09/2015 WS80A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD.
K153539 12/10/2015 RS80A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD.
K210068 01/11/2021 HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System Samsung Medison CO., LTD.
K210959 03/31/2021 RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System Samsung Medison CO., LTD.
K191055 04/19/2019 HS40 Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K211824 06/14/2021 HERA W9, HERA W10 Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K211945 06/23/2021 V8 Diagnostic Ultrasound System Samsung Medison CO., LTD.
K192505 09/12/2019 HS50/HS60 Diagnostics Ultrasound System Samsung Medison CO., LTD.
K182894 10/15/2018 HM70A Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K230084 01/11/2023 HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System Samsung Medison CO., LTD.


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