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.
K240631 03/06/2024 V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K241302 05/09/2024 SonoSync 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.
K242511 08/23/2024 V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultras 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.
K241971 07/05/2024 HERA Z20, R20, HERA Z30, R30 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.
K240516 02/23/2024 RS85 Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K242444 08/16/2024 HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System Samsung Medison Co., Ltd.
K233112 09/27/2023 HM70 EVO Diagnostic Ultrasound System Samsung Medison CO., LTD.
K250999 04/01/2025 V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultras Samsung Medison Co., Ltd.
K243702 11/29/2024 V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System Samsung Medison Co., Ltd.


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