Radiology AI Directory

FDA-cleared profile

EchoSolv AS

Echo IQ Ltd

Authorized purpose: Adjunctive assessment of severe aortic stenosis using transthoracic echocardiography data; an interpreting physician uses the output to facilitate diagnosis and must not rely on it alone for patient 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: Adjunctive assessment of severe aortic stenosis using transthoracic echocardiography data; an interpreting physician uses the output to facilitate diagnosis and must not rely on it alone for patient management.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Adjunctive assessment of severe aortic stenosis using transthoracic echocardiography data; an interpreting physician uses the output to facilitate diagnosis and must not rely on it alone for patient management.

Evidence takeaway

Evidence from the reviewed source record: FDA standalone testing used 6,268 retrospective studies with a reference standard based on U.S. board-certified cardiologist review of severe AS defined as AVA <=1.0 cm2; 2,483 were severe and 3,779 were not. The primary endpoint was AUROC 0.948 (95% CI 0.943-0.952). At the high-probability threshold, sensitivity was 0.801 (95% CI 0.786-0.818) and specificity was 0.923 (95% CI 0.915-0.932); low, medium, and high outputs also had DLRs of 0.067, 0.935, and 10.3. A separate one-site five-reader MRMC study used 200 TTE studies and reported assisted versus unassisted reader AUROC of 0.883 versus 0.865 and Fleiss kappa of 0.667 versus 0.641.

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
Adjunctive assessment of severe aortic stenosis using transthoracic echocardiography data; an interpreting physician uses the output to facilitate diagnosis and must not rely on it alone for patient management.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Board-certified cardiologists who review echocardiograms during evaluation and diagnosis of structural heart disease, specifically aortic stenosis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Routine clinical care and structural-heart-disease echocardiography; the device is described as stand-alone cloud-based software and the facility type is not specified.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Post-acquisition echocardiography decision support during physician review and final report generation, using clinician-reviewed measurements as an adjunct to current clinical practice guidelines.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Resting transthoracic echocardiogram measurements plus basic patient demographics including age and body surface area from height and weight; inputs are reviewed and approved by a trained clinical user. The packet also allows CSV upload for retrospective analysis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
A high, medium, or low severe-AS phenotype probability based on predicted aortic valve area of 1.0 cm2 or less, plus a guideline assessment based on aortic-jet peak velocity, aortic-valve mean gradient, and aortic-valve area.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Not intended for patients under 18 years of age or patients who have undergone aortic-valve replacement. A minimum input set is required for a valid probability output. Results are adjunctive and patient-management decisions must not be made solely from the device. The packet describes the algorithm as using available echo measurements rather than traditional LVOT measurements for the phenotype probability.
  • 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
K241245
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Heart, left ventricular outflow tract, and aortic valve
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-10-04
  • 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
Standalone cloud-based software using third-party systems for input and output; it can send datasets to the application and integrate outputs into end-user PACS or reporting software. CSV input is for retrospective analysis only. Exact interfaces, hosting boundaries, and local compatibility are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
Hybrid
  • 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 2026-09-08

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 EchoSolv AS; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission ยท 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 standalone testing used 6,268 retrospective studies with a reference standard based on U.S. board-certified cardiologist review of severe AS defined as AVA <=1.0 cm2; 2,483 were severe and 3,779 were not. The primary endpoint was AUROC 0.948 (95% CI 0.943-0.952). At the high-probability threshold, sensitivity was 0.801 (95% CI 0.786-0.818) and specificity was 0.923 (95% CI 0.915-0.932); low, medium, and high outputs also had DLRs of 0.067, 0.935, and 10.3. A separate one-site five-reader MRMC study used 200 TTE studies and reported assisted versus unassisted reader AUROC of 0.883 versus 0.865 and Fleiss kappa of 0.667 versus 0.641.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
80.1%(95% CI: 78.6%, 81.8%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

Reported specificity
92.3% (95% CI: 91.5%, 93.2%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

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

EchoSolv AS regulatory performance study summary

  • DesignStand-alone performance and reader study (ACR AI Central category)
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K241245
  • Samplen=6268
  • IndependenceIndependence not established

K241245

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 K241245 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 K241245. 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
2026-09-20Last searched
24Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 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 K241245: EchoSolv AS

    U.S. Food and Drug Administration - Published 2024-10-04 - 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. EchoSolv AS model card (K241245)

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

    Scope: intendedUsers, careSetting, output, reportedSensitivity, reportedSpecificity, evidenceSummary, anatomy, evidenceStudies

  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 K241245

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

    Scope: postmarketSafety

Research history

  1. K241245 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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