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Samsung Medison Co., Ltd.

Hongcheon-Gun, KR · 30 510(k) clearances

Total clearances
30
2020-01-06 → 2026-07-28
Last 12 months
3
Product codes
2
Most recent
2026-07-28
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Product codes worked

Code Device name Class Specialty Clearances Most recent
IYN System, Imaging, Pulsed Doppler, Ultrasonic Class II Radiology 29 2026-07-28
LLZ System, Image Processing, Radiological Class II Radiology 1 2024-08-23
Filings

All 510(k) clearances (30)

Date K-number Device Code Class Specialty
2026-07-28 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; IYN Class II Radiology
2026-03-27 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 Class II Radiology
2026-01-05 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 Class II Radiology
2025-07-18 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 Class II Radiology
2025-02-12 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 Class II Radiology
2024-12-10 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 Class II Radiology
2024-11-27 K242444 HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System IYN Class II Radiology
2024-10-11 K241971 HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System IYN Class II Radiology
2024-08-23 K241302 SonoSync LLZ Class II Radiology
2024-06-21 K240631 V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System IYN Class II Radiology
2024-06-12 K240516 RS85 Diagnostic Ultrasound System IYN Class II Radiology
2023-12-21 K233112 HM70 EVO Diagnostic Ultrasound System IYN Class II Radiology
2023-10-03 K231772 V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System IYN Class II Radiology
2023-04-21 K230084 HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System IYN Class II Radiology
2023-02-13 K223387 V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System IYN Class II Radiology
2022-08-22 K221599 HS40 Diagnostic Ultrasound System IYN Class II Radiology
2022-06-29 K220975 V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System IYN Class II Radiology
2022-06-17 K221117 RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System IYN Class II Radiology
2022-05-06 K220269 HM70 EVO Diagnostic Ultrasound System IYN Class II Radiology
2022-04-05 K220043 HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System IYN Class II Radiology
2021-09-09 K211824 HERA W9, HERA W10 Diagnostic Ultrasound System IYN Class II Radiology
2021-09-08 K211945 V8 Diagnostic Ultrasound System IYN Class II Radiology
2021-07-09 K210713 HM70 EVO Diagnostic Ultrasound System IYN Class II Radiology
2021-06-24 K210959 RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System IYN Class II Radiology
2021-05-13 K210426 HS40 Diagnostic Ultrasound System IYN Class II Radiology
2021-04-09 K210068 HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System IYN Class II Radiology
2020-10-30 K202556 HS30 Diagnostic Ultrasound System IYN Class II Radiology
2020-05-07 K200699 HS70A Diagnostic Ultrasound System IYN Class II Radiology
2020-04-07 K200339 HS40 Diagnostic Ultrasound System IYN Class II Radiology
2020-01-06 K192903 RS85 Diagnostic Ultrasound System IYN Class II Radiology