Radiology AI Directory

FDA-cleared profile

Ligence Heart

Ligence, UAB

Automated post-processing and measurement of adult transthoracic echocardiograms to support cardiologist/sonographer review and clinical decision-making.

Cardiac imagingQuantification and segmentationUltrasound workflow
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
Automated post-processing and measurement of adult transthoracic echocardiograms to support cardiologist/sonographer review and clinical decision-making.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Qualified cardiologists or sonographers.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Routine echocardiography workflow using a personal computer and compatible PACS; the packet does not specify a particular facility type.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Fully automated view classification, cardiac-cycle selection, border detection, measurement, report generation, guideline-range comparison, and clinician review/edit/replace support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Acquired adult transthoracic cardiac ultrasound DICOM studies/echocardiographic images received from a compatible PACS.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Four core automated LV measurements: lateral mitral-annular early-diastolic velocity (lateral e'), LVEDV by biplane Method of Disks, LVEF by biplane Method of Disks, and LVESV by biplane Method of Disks. Results are inserted into an editable PACS-compatible structured report with reference-guideline comparisons and can be exported as PDF; users can accept, edit, supplement, or replace automated measurements.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Adult patients only. Not validated for congenital heart disease, valve disease, pericardial disease, or intracardiac lesions such as tumors or thrombi. Poor image capture, non-cardiac probes, suboptimal gain/contrast/depth, prosthetic or surgically altered valves, intracardiac devices, and irregular non-sinus rhythm may reduce measurement accuracy. If gender is missing, female-referenced guideline values are used; if BSA is missing, indexed values cannot be provided. Clinician supervision and review remain required.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K252105
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Heart, including left-ventricular structure and function
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-09-26
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Designed for a personal computer receiving images from a compatible PACS; DICOM compliance and PACS-compatible structured reporting are stated. Completed reports export as PDF. The packet does not establish a current commercial deployment or security posture.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

Result destination

PACS is explicitly referenced as a result destination.

exact submission · checked 2026-09-01

Confirm supported products, versions, routing behavior, and display requirements during local evaluation.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Ligence Heart; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-08
Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
FDA packet: formal retrospective non-interventional validation at an independent U.S. echocardiography core laboratory using 600 previously acquired echocardiograms; 76 were excluded for missing views or corrupt metadata, leaving 524 studies assessed by three human readers. The four claimed measurements met the stated IEC non-inferiority criterion; no device-related adverse events or malfunctions occurred during the study.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Ligence Heart regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K252105
  • Samplen=524
  • IndependenceIndependence not established

K252105

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

No public price or quote for the exact K252105 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The exact-identifier FDA recall query returned no native recall record for K252105. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-08Last searched
22Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA K252105: Ligence Heart

    U.S. Food and Drug Administration - Published 2025-09-26 - Accessed 2026-09-08

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. Ligence Heart model card (K252105)

    American College of Radiology - Published 2026-07-16 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K252105

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K252105 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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