EchoPAC Software Only / EchoPAC Plug-in

K251342

GE Medical Systems Ultrasound and Primary Care Diagnostics · cleared 2025-07-16 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.”

AlgorithmAI based algorithm for auto-tracing of additional doppler spectrums

source quote (p.7)

“AI Cardiac Auto Doppler: AI based algorithm for auto-tracing of additional doppler spectrums added to the predicate Cardiac Auto Doppler available in the predicate EchoPAC Software Only / EchoPAC Plug-in (K220940), introducing additional heart valve related measurements compared to the predicate Spectrum Recognition algorithm available in EchoPAC Software Only / EchoPAC Plug-in (K220940).”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=1,369 patients

endpoints: feasibility score of more than 95%; accuracy threshold calculated as the mean absolute difference in percentage for each measured parameter; mean percent absolute error across all cardiac cycles against a threshold; predefined metric quantifying agreement between manual and AI-derived peak velocities

standards: ISO 14971, Application of risk management to medical devices, 2019, NEMA PS 3.1 - 3.20, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology), 2024e, IEC 62304 Edition 1.1 2015 - Medical device software - Software life cycle process, IEC 62366-1: 2015 + A1:2020 – Medical Device-Part 1: Application of Usability

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).