EchoPAC Software Only / EchoPAC Plug-in— 510(k) K251342

Name: FDA 510(k) clearance K251342
Creator: U.S. Food and Drug Administration
Published: 2025-07-16

Substantially Equivalent

GE Medical Systems Ultrasound and Primary Care Diagnostics

FDA 510(k) clearance K251342 for EchoPAC Software Only / EchoPAC Plug-in, Substantially Equivalent on 2025-07-16. Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics. Device class: 2.

Clearance details

Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-04-30
Decision date: 2025-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.