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Samsung Medison Co., Ltd.

FDA 510(k) & PMA Approved Devices — 55 products

Total Devices55
Categories2
Latest FDA decision2026-07-28
TypeNumberDevice NameCodeDateActions
510(k) K261412 V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;IYN2026-07-28 View
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 SystemIYN2026-03-27 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 SystemIYN2026-01-05 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 SystemIYN2025-07-18 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 SystemIYN2025-02-12 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 SystemIYN2024-12-10 View
510(k) K242444 HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemIYN2024-11-27 View
510(k) K241971 HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemIYN2024-10-11 View
510(k) K241302 SonoSyncLLZ2024-08-23 View
510(k) K240631 V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemIYN2024-06-21 View
510(k) K240516 RS85 Diagnostic Ultrasound SystemIYN2024-06-12 View
510(k) K233112 HM70 EVO Diagnostic Ultrasound SystemIYN2023-12-21 View
510(k) K231772 V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound SystemIYN2023-10-03 View
510(k) K230084 HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemIYN2023-04-21 View
510(k) K223387 V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemIYN2023-02-13 View
510(k) K221599 HS40 Diagnostic Ultrasound SystemIYN2022-08-22 View
510(k) K220975 V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemIYN2022-06-29 View
510(k) K221117 RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemIYN2022-06-17 View
510(k) K220269 HM70 EVO Diagnostic Ultrasound SystemIYN2022-05-06 View
510(k) K220043 HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemIYN2022-04-05 View

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