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Samsung Medison Co., Ltd.

FDA 510(k) & PMA Approved Devices — 54 products

Total Devices54
Categories2
Latest Approval2026-03-27
TypeNumberDevice NameCodeDate
510(k) K254099 EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System IYN 2026-03-27 View
510(k) K252018 HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System IYN 2026-01-05 View
510(k) K250999 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 Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System IYN 2025-07-18 View
510(k) K243702 V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System IYN 2025-02-12 View
510(k) K242511 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 Ultrasound System IYN 2024-12-10 View
510(k) K242444 HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System IYN 2024-11-27 View
510(k) K241971 HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System IYN 2024-10-11 View
510(k) K241302 SonoSync LLZ 2024-08-23 View
510(k) K240631 V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System IYN 2024-06-21 View
510(k) K240516 RS85 Diagnostic Ultrasound System IYN 2024-06-12 View
510(k) K233112 HM70 EVO Diagnostic Ultrasound System IYN 2023-12-21 View
510(k) K231772 V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System IYN 2023-10-03 View
510(k) K230084 HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System IYN 2023-04-21 View
510(k) K223387 V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System IYN 2023-02-13 View
510(k) K221599 HS40 Diagnostic Ultrasound System IYN 2022-08-22 View
510(k) K220975 V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System IYN 2022-06-29 View
510(k) K221117 RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System IYN 2022-06-17 View
510(k) K220269 HM70 EVO Diagnostic Ultrasound System IYN 2022-05-06 View
510(k) K220043 HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System IYN 2022-04-05 View
510(k) K211824 HERA W9, HERA W10 Diagnostic Ultrasound System IYN 2021-09-09 View
510(k) K211945 V8 Diagnostic Ultrasound System IYN 2021-09-08 View
510(k) K210713 HM70 EVO Diagnostic Ultrasound System IYN 2021-07-09 View
510(k) K210959 RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System IYN 2021-06-24 View
510(k) K210426 HS40 Diagnostic Ultrasound System IYN 2021-05-13 View
510(k) K210068 HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System IYN 2021-04-09 View
510(k) K202556 HS30 Diagnostic Ultrasound System IYN 2020-10-30 View
510(k) K200699 HS70A Diagnostic Ultrasound System IYN 2020-05-07 View
510(k) K200339 HS40 Diagnostic Ultrasound System IYN 2020-04-07 View
510(k) K192903 RS85 Diagnostic Ultrasound System IYN 2020-01-06 View
510(k) K192505 HS50/HS60 Diagnostics Ultrasound System IYN 2019-12-12 View
510(k) K192319 HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System IYN 2019-12-10 View
510(k) K192030 RS80 EVO Diagnostic Ultrasound System IYN 2019-09-19 View
510(k) K191055 HS40 Diagnostic Ultrasound System IYN 2019-06-12 View
510(k) K191115 RS85 Diagnostic Ultrasound System IYN 2019-06-12 View
510(k) K190444 HERA I10 Diagnostic Ultrasound System IYN 2019-05-22 View
510(k) K182932 RS85 Diagnostic Ultrasound System IYN 2019-02-15 View
510(k) K182894 HM70A Diagnostic Ultrasound System IYN 2019-01-22 View
510(k) K182632 HS30 Diagnostic Ultrasound System IYN 2019-01-08 View
510(k) K182595 HERA W10 Diagnostic Ultrasound System IYN 2018-12-18 View
510(k) K181336 HS50 / HS60 Diagnostic Ultrasound System IYN 2018-12-04 View
510(k) K180883 5D Viewer LLZ 2018-05-15 View
510(k) K180409 HS40 Diagnostic Ultrasound System IYN 2018-05-11 View
510(k) K173713 HS70A Diagnostic Ultrasound System IYN 2018-03-08 View
510(k) K173513 WS80A Diagnostic Ultrasound System IYN 2018-02-20 View
510(k) K173204 RS85 Diagnostic Ultrasound System IYN 2018-02-05 View
510(k) K171048 RS80A Diagnostic Ultrasound System IYN 2017-08-24 View
510(k) K171070 WS80A Diagnostic Ultrasound System IYN 2017-08-09 View
510(k) K172129 HS40 Diagnostic Ultrasound System IYN 2017-08-08 View
510(k) K170493 HS50 / HS60 Diagnostic Ultrasound System IYN 2017-03-28 View
510(k) K163691 HS70A Diagnostic Ultrasound System IYN 2017-02-22 View
510(k) K153539 RS80A Diagnostic Ultrasound System IYN 2016-10-03 View
510(k) K162094 RS80A Diagnostic Ultrasound System IYN 2016-08-26 View
510(k) K161955 5D Viewer LLZ 2016-08-10 View
510(k) K153529 WS80A Diagnostic Ultrasound System IYN 2016-02-02 View
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