Radiology AI Directory

FDA-cleared profile

Ligence Heart

Ligence Uab

Ligence Heart is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, automatically producing a full report with measurements of several key cardiac structural and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists or sonographers for clinical decision making. Ligence Heart is indicated for use in adult patients. Ligence Heart has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g., tumors, thrombi). Limitations: Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality. Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions. If no gender is present, female referenced guideline values will be used for conclusions. If Body Surface Area (BSA) is not present, indexed values cannot be provided. During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, or use of suboptimal settings (e.g., gain, contrast, depth) may lead to lower accuracy of the software. Ligence Heart has not been validated in patients with prosthetic or surgically altered cardiac valves, implantable intracardiac devices, or irregular (non-sinus) rhythm; these conditions may affect automated measurement accuracy.

Cardiac imagingOncology quantificationQuantification 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.

Product overview

Start with the essentials

Ligence Heart is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, automatically producing a full report with measurements of several key cardiac structural and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists or sonographers for clinical decision making. Ligence Heart is indicated for use in adult patients. Ligence Heart has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g., tumors, thrombi). Limitations: Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality. Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions. If no gender is present, female referenced guideline values will be used for conclusions. If Body Surface Area (BSA) is not present, indexed values cannot be provided. During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, or use of suboptimal settings (e.g., gain, contrast, depth) may lead to lower accuracy of the software. Ligence Heart has not been validated in patients with prosthetic or surgically altered cardiac valves, implantable intracardiac devices, or irregular (non-sinus) rhythm; these conditions may affect automated measurement accuracy.

Overview status: Field-derived fact summary This section is assembled from the sourced field records below; it is not a source-reviewed editorial overview.

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
Ligence Heart is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, automatically producing a full report with measurements of several key cardiac structural and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists or sonographers for clinical decision making. Ligence Heart is indicated for use in adult patients. Ligence Heart has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g., tumors, thrombi). Limitations: Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality. Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions. If no gender is present, female referenced guideline values will be used for conclusions. If Body Surface Area (BSA) is not present, indexed values cannot be provided. During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, or use of suboptimal settings (e.g., gain, contrast, depth) may lead to lower accuracy of the software. Ligence Heart has not been validated in patients with prosthetic or surgically altered cardiac valves, implantable intracardiac devices, or irregular (non-sinus) rhythm; these conditions may affect automated measurement accuracy.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08

The available FDA packet is a clearance letter without usable indication detail; this wording comes from the exact-submission ACR model card and does not replace FDA labeling.

Intended users
Qualified cardiologists or sonographers
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Intended-user text reported in the exact-submission ACR model card.

Care setting and population
Adult transthoracic echocardiography workflows; the institutional setting is not established by the reviewed exact-submission sources.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Measurement or quantification
  • Public source
  • Exact FDA submission
  • Checked 2026-08-31

Conservative normalization of explicit wording in an exact-submission source.

Required input
Ultrasound images or data involving Heart/Cardiovascular; consult the FDA labeling for exact protocol, series, and quality requirements.
  • Public source
  • Exact FDA submission
  • Checked 2026-08-31

Conservative normalization of explicit wording in an exact-submission source.

Output and human action
The software automatically produces a full report with measurements of several key cardiac structural and functional parameters from transthoracic cardiac ultrasound images, intended to support clinical decision making by cardiologists or sonographers.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Clinical output reported in the exact-submission ACR model card.

Limitations
Exclusion criteria: Patients with congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g., tumors, thrombi); patients with prosthetic or surgically altered cardiac valves; patients with implantable intracardiac devices; patients with irregular (non-sinus) rhythm; poor quality images
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Limitations and supported-acquisition details reported in the exact-submission ACR model card.

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
K253535
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Anatomy
Heart/Cardiovascular
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Anatomy normalized from explicit exact-submission ACR model-card wording.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-02-27
  • 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
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

Attach protocol-level DICOM, HL7, FHIR, PACS, RIS, EHR, or orchestrator documentation.

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.

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

No exact-version evidence summary has been curated yet.

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.

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 K253535 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 K253535. 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
18Fields 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, acr ai central product, fda decision summary, 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 K253535: Ligence Heart

    U.S. Food and Drug Administration - Published 2026-02-27 - 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 (K253535)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, limitations, anatomy

  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 K253535

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

    Scope: postmarketSafety

Research history

  1. K253535 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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