GE Medical Systems Ultrasound and Primary Care Diagnostics · Class II · Cleared Jul 16, 2025
| K-number | K251342 |
| Device name | EchoPAC Software Only / EchoPAC Plug-in |
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| Product code | QIH |
| Device class | Class II |
| Decision date | Jul 16, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.2050 |
EchoPAC Software Only / EchoPAC Plug-in is workstation software for diagnostic review, analysis, measurement, and reporting of ultrasound images acquired from GE Healthcare ultrasound systems and DICOM images from other ultrasound systems. It enables post-processing of 2D, 3D, and 4D ultrasound data across clinical applications including cardiac, obstetric, abdominal, vascular, and musculoskeletal imaging, for use by licensed physicians.
The proposed device employs the same fundamental scientific technology as its predicate. New features include AI Cardiac Auto Doppler (automated Doppler spectrum tracing), combined 4D Auto LHQ measurement tool, enhanced visualization modes (Clarity+, Soft Rendering, RadiantFlow, Silhouette), improved workflow tools (2-Click Crop, 2-Click Align, Flexi-Slice enhancements), LAA sizing and device compression tools, and expanded DICOM support enabling PISA, AFI LA, and AFI RV measurements on third-party acquisition data. Cloud-based software licensing replaces physical USB dongles.
ISO 14971 (risk management), NEMA PS 3.1-3.20 (DICOM), IEC 62304 Edition 1.1 2015 (software life cycle), and IEC 62366-1:2015 + A1:2020 (usability). Quality assurance included risk analysis, requirements and design reviews, module-level testing, integration testing, performance testing, and safety testing.
The device is substantially equivalent because it maintains identical clinical indications for use as the predicate K220940, employs the same fundamental imaging processing technology, and new features are modifications or combinations of existing predicate capabilities or reference device features. AI Auto Doppler performance was verified against manually-measured reference standards across diverse patient populations, ultrasound systems, and demographics, demonstrating mean absolute error within acceptance criteria. All new measurement tools (TSP Height, LAA Device Compression, LAA Sizing) are based on established caliper and ROI tracing methodologies already present in predicate software.
View the full FDA submission: accessdata.fda.gov