EchoPAC Software Only, EchoPAC Plug-In

K200852

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

FDA 510(k) summary for EchoPAC Software Only, EchoPAC Plug-In (K200852)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
4
Performance observations
0
Product code
LLZ
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“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. 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.”
AlgorithmAI Artificial Intelligence based Cardiac Auto 2D feature and AI based Spectrum Recognition feature
source quote (p.6)
“It is AI Artificial Intelligence) based Cardiac Auto 2D feature that enables semi-automated measurements on a PLAX image. 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
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

standards: ISO 14971:2007, NEMA PS 3.1 -3.20 Digital Imaging and Communications in Medicine (DICOM) Set, (Radiology), 2016, IEC 62304:2006 A1 2015, IEC 62366-1: 2015

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

25
recalls in product code, 24mo
397
MAUDE reports in code, 12mo
+963%
vs code's own 3-yr baseline
42
drift signals on this device
  • predicate_cohort_contagion

    K200852 shares predicate K170847 with K251342 (EchoPAC Software Only / EchoPAC Plug-in), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K170847 sibling:K251342

  • predicate_cohort_contagion

    K200852 shares predicate K181685 with K200497 (Vivid S60N, Vivid S70N), whose product code IYN recorded 85 recall event(s) in the trailing 24 months.

    first seen 2026-07-22 · predicate:K181685 sibling:K200497

  • predicate_cohort_contagion

    K200852 shares predicate K181685 with K200708 (Vivid iq), whose product code IYN recorded 85 recall event(s) in the trailing 24 months.

    first seen 2026-07-22 · predicate:K181685 sibling:K200708

  • predicate_cohort_contagion

    K200852 shares predicate K181685 with K200743 (Vivid E80/ Vivid E90/ Vivid E95), whose product code IYN recorded 85 recall event(s) in the trailing 24 months.

    first seen 2026-07-22 · predicate:K181685 sibling:K200743

  • predicate_cohort_contagion

    K200852 shares predicate K181685 with K200851 (Vivid T8, Vivid T9), whose product code IYN recorded 85 recall event(s) in the trailing 24 months.

    first seen 2026-07-22 · predicate:K181685 sibling:K200851

  • predicate_cohort_contagion

    K200852 shares predicate K181685 with K220882 (Vivid E80, Vivid E90, Vivid E95), whose product code IYN recorded 85 recall event(s) in the trailing 24 months.

    first seen 2026-07-22 · predicate:K181685 sibling:K220882

  • …and 36 more.

Recalls attributed to this device

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.

    recall event 98428 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.

    recall event 98428 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.

    recall event 98428 (openFDA)

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 2026-09-02.

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.

Related FDA clearances

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These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K200852