Radiology AI Directory

FDA-cleared profile

EchoGo Pro

Ultromics Ltd

Authorized purpose: Adjunct to diagnostic stress echocardiography for patients undergoing assessment for coronary artery disease; an interpreting physician uses the output as information that may assist diagnosis, not as the sole basis for management.

Cardiac imagingUltrasound 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: Adjunct to diagnostic stress echocardiography for patients undergoing assessment for coronary artery disease; an interpreting physician uses the output as information that may assist diagnosis, not as the sole basis for management.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Adjunct to diagnostic stress echocardiography for patients undergoing assessment for coronary artery disease; an interpreting physician uses the output as information that may assist diagnosis, not as the sole basis for management.

Evidence takeaway

Evidence from the reviewed source record: FDA K201555 reports performance testing for reader improvement, inter-operator agreement, and native system performance. The primary reader-performance increase was AUROC difference 0.054 (95% CI 0.032-0.077; p=0.02), exceeding the predicate comparison. Native system AUROC was 0.927, with sensitivity 0.844 (95% CI 0.739-0.950) and specificity 0.927 (95% CI 0.878-0.976). Kendall Tau-B agreement increased from 0.58 (95% CI 0.48-0.69) unaided to 0.82 (95% CI 0.72-0.93) with EchoGo Pro (p<0.001). AUROC and agreement are distinct from sensitivity and specificity; the reviewed packet text does not state the performance cohort size.

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
Adjunct to diagnostic stress echocardiography for patients undergoing assessment for coronary artery disease; an interpreting physician uses the output as information that may assist diagnosis, not as the sole basis for management.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Interpreting physicians; trained operators review and approve the automatically generated contour traces.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Diagnostic stress-echocardiography workflow; the FDA packet does not specify a facility type.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
User-reviewed ROI/contour and machine-learning decision-support/reporting aid for stress echocardiography; it is an adjunct and not for primary diagnosis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
Anonymized DICOM 3.0-compliant stress-echocardiography datasets containing apical two-chamber, apical four-chamber, and mid-ventricular short-axis views at rest and peak stress, with required view labels/metadata.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Automatically detected LV endocardial contours reviewed and approved by trained operators, geometric parameters, and a report with a two-level categorical assessment of whether the stress-echo ROIs suggest a higher or lower possibility of significant CAD, defined in the packet as >=70% stenosis in specified coronary segments.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
Patient management must not rely solely on the analysis. The packet states that v1.0.2 was not validated in patients with prior CABG and is not intended for mild or moderate myocardial ischemia, coronary-disease localization, myocardial perfusion, myocardial viability, or valve disease.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

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
K201555
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Heart, especially the left ventricle and stress-echocardiographic A2C, A4C, and mid-ventricular SAX views.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2020-12-18
  • 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
DICOM 3.0 input, Windows operation on off-the-shelf hardware, and a report returned to the physician are described; a specific PACS, RIS, EHR, routing interface, or local compatibility configuration is not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
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
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

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 2026-09-09

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 2026-09-09

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

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

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

exact submission · checked 2026-09-09
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 K201555 reports performance testing for reader improvement, inter-operator agreement, and native system performance. The primary reader-performance increase was AUROC difference 0.054 (95% CI 0.032-0.077; p=0.02), exceeding the predicate comparison. Native system AUROC was 0.927, with sensitivity 0.844 (95% CI 0.739-0.950) and specificity 0.927 (95% CI 0.878-0.976). Kendall Tau-B agreement increased from 0.58 (95% CI 0.48-0.69) unaided to 0.82 (95% CI 0.72-0.93) with EchoGo Pro (p<0.001). AUROC and agreement are distinct from sensitivity and specificity; the reviewed packet text does not state the performance cohort size.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Native EchoGo Pro system sensitivity: 0.844 (95% CI 0.739-0.950) in the FDA performance testing.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

This is a native system endpoint; the primary reader AUROC delta and Kendall Tau-B agreement are separate measures, and the packet text reviewed here does not state the cohort size.

Reported specificity
Native EchoGo Pro system specificity: 0.927 (95% CI 0.878-0.976) in the FDA performance testing.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

This preserves the named FDA endpoint and prevents the reader AUROC or agreement values from being treated as specificity.

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

EchoGo Pro regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K201555
  • IndependenceIndependence not established

K201555

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 2026-09-09

No public price or quote for the exact K201555 configuration was established in this review.

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

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 K201555. 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 2026-09-09

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
23Fields reviewed
9Source classes checked
3Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 3 PubMed and 1 ClinicalTrials.gov candidate records. 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 3 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, 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 K201555: EchoGo Pro

    U.S. Food and Drug Administration - Published 2020-12-18 - Accessed 2026-09-09

    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. EchoGo Pro model card (K201555)

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

    Scope: intendedUsers, 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 K201555

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

    Scope: postmarketSafety

Research history

  1. K201555 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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