510(k) clearance

EchoPAC Software Only / EchoPAC Plug-in (v211)

FDA 510(k) source

510(k) number

K261623

Applicant

GE Medical Systems Ultrasound and Primary Care Diagnostics

Decision date

Sep 16, 2026

Date received

May 15, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

QIH

Device type

Automated Radiological Image Processing Software

Device class

Class II

Regulation

21 CFR 892.2050

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Waukesha, WI, US