EchoPAC Software Only, EchoPAC Plug-in

K220940

GE Medical Systems Ultrasound and Primary Care Diagnostics, · cleared 2022-07-22 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“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.”
AlgorithmAI Auto ROI algorithm
source quote (p.6)
“Added Easy AutoEF -based on AutoEF 3.0 (includes AI Auto ROI algorithm)”
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)

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)

diceas written: “average dice score”0.92
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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • 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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K220940