EchoPAC Software Only, EchoPAC Plug-in
K220940GE Medical Systems Ultrasound and Primary Care Diagnostics, · cleared 2022-07-22 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“EchoPAC Software Only / EchoPAC Plug-in provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the GE Healthcare Vivid family of ultrasound systems, as well as DICOM images from other ultrasound systems. EchoPAC Software Only will be offered as SW only to be installed directly on customer PC hardware and EchoPAC Plug-in is intended to be hosted by a generalized PACS host workstation.”
source quote (p.6)
“Added Easy AutoEF -based on AutoEF 3.0 (includes AI Auto ROI algorithm)”
Validation studies (1)
Retrospective clinical
n=45 patients
endpoints: Accuracy (average dice score)
standards: ISO 14971, NEMA PS 3.1 – 3.20, IEC 62304:2006 A1 2015, IEC 62366-1: 2015
Reported performance (1 observation)
source quote (p.7)
“The accuracy of the AI algorithm (average dice score) as tested on datasets from different countries, is 92% or higher; as tested on datasets from different scanning views, is 91% or higher; as tested on dataset from different left ventricle volumes, is 92% or higher.”
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K251342 (decision 2025-07-16) from GE Medical Systems Ultrasound and Primary Care Diagnostics for a matching device line ("EchoPAC Software Only / EchoPAC Plug-in") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251342
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).