Radiology AI Directory

FDA-cleared profile

EchoGo Core

Ultromics Ltd

Authorized purpose: EchoGo Core automatically measures ejection fraction, global longitudinal strain, and left-ventricular volume from echocardiograms and reports the measurements to a clinician within the labeled workflow.

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.

Product overview

Start with the essentials

Authorized purpose: EchoGo Core automatically measures ejection fraction, global longitudinal strain, and left-ventricular volume from echocardiograms and reports the measurements to a clinician within the labeled workflow.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: EchoGo Core automatically measures ejection fraction, global longitudinal strain, and left-ventricular volume from echocardiograms and reports the measurements to a clinician within the labeled workflow.

Evidence takeaway

Evidence from the reviewed source record: The exact FDA submission K191171 is the identity anchor. Its public decision material supports the submission-specific product and intended-use summary recorded here; it does not establish a general product-wide sensitivity or specificity value for this dossier.

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
EchoGo Core automatically measures ejection fraction, global longitudinal strain, and left-ventricular volume from echocardiograms and reports the measurements to a clinician within the labeled workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Qualified cardiologists, radiologists, sonographers, technologists, and trained imaging professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Cardiac imaging departments and workstations using the exact cleared acquisition or analysis workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Cardiac image acquisition, measurement, visualization, or workflow support for professional interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Supported cardiac ultrasound or CT/CTA image data and release-specific metadata.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Cardiac images, measurements, quantitative values, or reports for qualified professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
Acquisition protocol, modality, contrast, rhythm, anatomy, image quality, population, and output-review limits are release-specific. EchoGo Core automatically measures ejection fraction, global longitudinal strain, and left-ventricular volume from echocardiograms and reports the measurements to a clinician within the labeled workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

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
K191171
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Heart/Cardiovascular
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2019-11-13
  • 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
Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.

Deployment and data flow
On-premise
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Public sources reviewed here do not establish the complete exact-release security posture, including identity, audit, encryption, retention, remote access, vulnerability management, backup, or incident response.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.

Workflow role

Cardiac image acquisition, measurement, visualization, or workflow support for professional interpretation.

exact submission · checked 2026-09-04

This is a submission-anchored intended-use summary, not a local acceptance result.

Source

Input

Supported cardiac ultrasound or CT/CTA image data and release-specific metadata.

exact submission · checked 2026-09-04

Exact supported inputs and protocol limits must be confirmed from the complete labeling.

Source

Output

Cardiac images, measurements, quantitative values, or reports for qualified professional review.

exact submission · checked 2026-09-04

Output review, editing, and downstream use remain release- and site-specific.

Source

Vendor family context

Current vendor material is product-family context for K191171 only; exact release, enabled options, deployment, and local interoperability require confirmation.

product family · checked 2026-09-04

Vendor material is not exact-release evidence unless that linkage is separately proven.

Source

Site validation status

Exact local interfaces, deployment topology, security controls, downtime behavior, and support obligations remain unestablished.

exact submission · checked 2026-09-04

Obtain organization-specific implementation evidence before procurement or clinical use.

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
The exact FDA submission K191171 is the identity anchor. Its public decision material supports the submission-specific product and intended-use summary recorded here; it does not establish a general product-wide sensitivity or specificity value for this dossier.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact submission and version-linked sensitivity endpoint is published in this dossier; do not substitute a product-family or candidate-study value.

Reported specificity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact submission and version-linked specificity endpoint is published in this dossier; do not substitute a product-family or candidate-study value.

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

FDA submission-specific verification and validation evidence for K191171

  • DesignRegulatory verification, validation, and labeling evidence reviewed for exact FDA submission K191171.
  • PopulationThe labeled population and test materials for exact submission K191171; a general clinical study population is not established here.
  • Scopeexact submission
  • Tested versionEchoGo Core (K191171)
  • IndependenceSponsor or vendor study

K191171

FDA regulatory evidence is submission-specific but is not independent clinical performance evidence.

Source

1 unlinked candidate evidence record is retained for source review and excluded from this evidence display.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No public exact-release price, license fee, subscription, contract, or implementation cost was established in this review.

Reimbursement and coding
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

CMS index context was checked, but no product-specific coverage or reimbursement determination is inferred.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

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
2026-09-20Last searched
28Fields reviewed
14Source classes checked
0Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 0 PubMed and 1 ClinicalTrials.gov candidate record. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 0 PubMed and 1 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, acr ai central product, vendor product page, implementation documentation, reimbursement policy, peer reviewed literature, clinical trial registry, 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 decision summary for K191171 - EchoGo Core

    U.S. Food and Drug Administration - Published 2019-11-13 - Accessed 2026-09-04

    Scope: regulatoryIdentity, productIdentity, indication, modality, anatomy, workflowRole, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. EchoGo Core model card (K191171)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

  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. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  7. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  8. Ultromics EchoGo family context

    Ultromics - Accessed 2026-09-04

    Scope: productFamilyContext, workflowRole, implementationCapabilities

  9. Mazankowski Alberta Heart Institute (MAHI) EchoGo Discovery 1 Protocol

    U.S. National Library of Medicine - Accessed 2026-09-04

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

Research history

  1. K191171 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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