510(k) clearance

V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic Ultrasound System; XH10 Diagnostic Ultrasound System; V10 ONE Diagnostic Ultrasound System; cV10 ONE Diagnostic Ultrasound System; H10 ONE Diagnostic Ultrasound System; XV10 ONE Diagnostic Ultrasound System; XH10 ONE Diagnostic Ultrasound System; HERA Z10 Diagnostic Ultrasound System

FDA 510(k) source

510(k) number

K263150

Applicant

Samsung Medison Co., Ltd.

Decision date

Oct 8, 2026

Date received

Sep 8, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

IYN

Device type

System, Imaging, Pulsed Doppler, Ultrasonic

Device class

Class II

Regulation

21 CFR 892.1550

Advisory committee

Radiology

Statement or summary

Summary

Third party

Y

Location

Hongcheon-Gun, KR