EchoPAC Software Only, EchoPAC Plug-In

K200852

GE Medical Systems Ultrasound and Primary Care Diagnostics · cleared 2020-09-18 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“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 will be offered as SW-only to be installed directly on customer PC hardware, and EchoPAC Plug-in will be offered as an accessory to image management workstations. It is AI (Artificial Intelligence) based Cardiac Auto 2D feature that enables semi-automated measurements on a PLAX image.”

AlgorithmAI (Artificial Intelligence) based Cardiac Auto 2D feature; AI based Spectrum Recognition feature

source quote (p.6)

“AI Auto Measure 2D: same feature as cleared on Vivid E95 (K200743). It is AI (Artificial Intelligence) based Cardiac Auto 2D feature that enables semi-automated measurements on a PLAX image. AI Auto Measure - Spectrum Recognition: same feature as cleared on Vivid E95 (K200743). It is AI based Spectrum Recognition feature that enables automated recognition of common Doppler spectra and automatically starts the Auto Doppler measurement or opens the appropriate manual measurement folder.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

standards: ISO 14971:2007 - Medical devices - Application of risk management to medical devices, NEMA PS 3.1 -3.20 Digital Imaging and Communications in Medicine (DICOM) Set, (Radiology), 2016, IEC 62304:2006 A1 2015 - Medical device software - Software life cycle process, IEC 62366-1: 2015 – 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

295

MAUDE reports in code, 12mo

+683%

vs code's own 3-yr baseline

drift signals on this device

recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems, LLC, initiated 2026-01-30): "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w" Recalling firm matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:98428
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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K220940 (decision 2022-07-22) 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:K220940
adverse_event_inflection
MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.
first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99042
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98520
…and 22 more.

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).