Samsung Medison Co., Ltd. - FDA 510(k) Cleared Devices

Cleared Jul 28, 2026

V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound...

K261412 · IYN

Radiology · 89d

Cleared Mar 27, 2026

EVO Q30 Diagnostic Ultrasound System

K254099 · IYN

Radiology · 98d

Cleared Jan 05, 2026

HERA Z20 Diagnostic Ultrasound System

K252018 · IYN

Radiology · 189d

Cleared Jul 18, 2025

V8 Diagnostic Ultrasound System

K250999 · IYN

Radiology · 108d

Cleared Feb 12, 2025

V8 Diagnostic Ultrasound System

K243702 · IYN

Radiology · 75d

Cleared Dec 10, 2024

V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5...

K242511 · IYN

Radiology · 109d

Cleared Nov 27, 2024

HERA W10 Diagnostic Ultrasound System

K242444 · IYN

Radiology · 103d

Cleared Oct 11, 2024

HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System

K241971 · IYN

Radiology · 98d

Cleared Aug 23, 2024

SonoSync

K241302 · LLZ

Radiology · 106d

Cleared Jun 21, 2024

V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System

K240631 · IYN

Radiology · 107d

Cleared Jun 12, 2024

RS85 Diagnostic Ultrasound System

K240516 · IYN

Radiology · 110d

Cleared Dec 21, 2023

HM70 EVO Diagnostic Ultrasound System

K233112 · IYN

Radiology · 85d