Medical Device Manufacturer · KR , Seoul

Samsung Medison Co., Ltd.

71 submissions · 71 cleared · Since 2011
71
Total
71
Cleared
0
Denied

Samsung Medison Co., Ltd. — FDA 510(k) Submissions

Samsung Medison Co., Ltd. has submitted 71 FDA 510(k) premarket notifications since 2011, of which 71 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Imaging, Pulsed Doppler, Ultrasonic, System, Image Processing, Radiological, System, Imaging, Pulsed Echo, Ultrasonic . Use the specialty filter in the sidebar to narrow results.

71 devices
1–25 of 71
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
K252018 · IYN System, Imaging, Pulsed... · Radiology
Jan 2026 189d
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
K250999 · IYN System, Imaging, Pulsed... · Radiology
Jul 2025 108d
V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System
K243702 · IYN System, Imaging, Pulsed... · Radiology
Feb 2025 75d
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
K242511 · IYN System, Imaging, Pulsed... · Radiology
Dec 2024 109d
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
K242444 · IYN System, Imaging, Pulsed... · Radiology
Nov 2024 103d
HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System
K241971 · IYN System, Imaging, Pulsed... · Radiology
Oct 2024 98d
SonoSync
K241302 · LLZ System, Image Processing,... · Radiology
Aug 2024 106d
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
K240631 · IYN System, Imaging, Pulsed... · Radiology
Jun 2024 107d
RS85 Diagnostic Ultrasound System
K240516 · IYN System, Imaging, Pulsed... · Radiology
Jun 2024 110d
HM70 EVO Diagnostic Ultrasound System
K233112 · IYN System, Imaging, Pulsed... · Radiology
Dec 2023 85d
V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System
K231772 · IYN System, Imaging, Pulsed... · Radiology
Oct 2023 109d
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
K230084 · IYN System, Imaging, Pulsed... · Radiology
Apr 2023 100d
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
K223387 · IYN System, Imaging, Pulsed... · Radiology
Feb 2023 98d
HS40 Diagnostic Ultrasound System
K221599 · IYN System, Imaging, Pulsed... · Radiology
Aug 2022 81d
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
K220975 · IYN System, Imaging, Pulsed... · Radiology
Jun 2022 86d
RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
K221117 · IYN System, Imaging, Pulsed... · Radiology
Jun 2022 60d
HM70 EVO Diagnostic Ultrasound System
K220269 · IYN System, Imaging, Pulsed... · Radiology
May 2022 95d
HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System
K220043 · IYN System, Imaging, Pulsed... · Radiology
Apr 2022 90d
HERA W9, HERA W10 Diagnostic Ultrasound System
K211824 · IYN System, Imaging, Pulsed... · Radiology
Sep 2021 87d
V8 Diagnostic Ultrasound System
K211945 · IYN System, Imaging, Pulsed... · Radiology
Sep 2021 77d
HM70 EVO Diagnostic Ultrasound System
K210713 · IYN System, Imaging, Pulsed... · Radiology
Jul 2021 121d
RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
K210959 · IYN System, Imaging, Pulsed... · Radiology
Jun 2021 85d
HS40 Diagnostic Ultrasound System
K210426 · IYN System, Imaging, Pulsed... · Radiology
May 2021 91d
HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System
K210068 · IYN System, Imaging, Pulsed... · Radiology
Apr 2021 88d
HS30 Diagnostic Ultrasound System
K202556 · IYN System, Imaging, Pulsed... · Radiology
Oct 2020 57d
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