Cleared Traditional

EchoPAC Software Only / EchoPAC Plug-in

K251342 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
Jul 2025
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K251342 is an FDA 510(k) clearance for the EchoPAC Software Only / EchoPAC Plug-in, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics (Waukesha, US). The FDA issued a Cleared decision on July 16, 2025, 77 days after receiving the submission on April 30, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K251342 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2025
Decision Date July 16, 2025
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QIH — Automated Radiological Image Processing Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.