Company profile

Samsung Medison Co., Ltd.

Samsung Medison Co., Ltd. has 18 AI-enabled medical devices on the FDA list. The first decision was on May 13, 2021 and the most recent on January 5, 2026 (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). Its most common review panel is Radiology (18 devices).

18AI devices

2021First decision

2026Latest decision

1Specialties

Per year

202120222023202420252026

Samsung Medison Co., Ltd. AI devices per year: 2021 3, 2022 3, 2023 4, 2024 5, 2025 2, 2026 1

By specialty

Radiology18

Timeline

January 5, 2026 · 510(k) K252018HERA 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 · Radiology · IYN
July 18, 2025 · 510(k) K250999V8 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 · Radiology · IYN
February 12, 2025 · 510(k) K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System · Radiology · IYN
December 10, 2024 · 510(k) K242511V5 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 · Radiology · IYN
November 27, 2024 · 510(k) K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System · Radiology · IYN
October 11, 2024 · 510(k) K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System · Radiology · IYN
June 21, 2024 · 510(k) K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System · Radiology · IYN
June 12, 2024 · 510(k) K240516RS85 Diagnostic Ultrasound System · Radiology · IYN
December 21, 2023 · 510(k) K233112HM70 EVO Diagnostic Ultrasound System · Radiology · IYN
October 3, 2023 · 510(k) K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System · Radiology · IYN
April 21, 2023 · 510(k) K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System · Radiology · IYN
February 13, 2023 · 510(k) K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System · Radiology · IYN
August 22, 2022 · 510(k) K221599HS40 Diagnostic Ultrasound System · Radiology · IYN
June 29, 2022 · 510(k) K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System · Radiology · IYN
April 5, 2022 · 510(k) K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System · Radiology · IYN
September 9, 2021 · 510(k) K211824HERA W9, HERA W10 Diagnostic Ultrasound System · Radiology · IYN
September 8, 2021 · 510(k) K211945V8 Diagnostic Ultrasound System · Radiology · IYN
May 13, 2021 · 510(k) K210426HS40 Diagnostic Ultrasound System · Radiology · IYN