510(k) clearance

Vivid Explorer/Vivid Advanced/Vivid Focus

FDA 510(k) source

510(k) number

K261313

Applicant

GE Medical Systems Ultrasound and Primary Care Diagnostics

Decision date

Sep 2, 2026

Date received

Apr 21, 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

N

Location

Waukesha, WI, US