EchoSolv AS is a machine learning (ML) and artificial intelligence (AI)-based decision support software indicated for use as an adjunct to echocardiography for assessment of severe aortic stenosis (AS). When utilized by an interpreting physician, this device provides information to facilitate rendering an accurate diagnosis of AS. Patient management decisions should not be made solely on the results of the EchoSolv AS analysis. EchoSolv AS includes both the algorithm based AS phenotype analysis, and the application of recognized Aortic Stenosis clinical practice guidelines. Limitations: EchoSolv AS is not intended for patients under the age of 18 years or those who have previously undergone aortic valve replacement surgery.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
EchoSolv AS is a machine learning (ML) and artificial intelligence (AI)-based decision support software indicated for use as an adjunct to echocardiography for assessment of severe aortic stenosis (AS). When utilized by an interpreting physician, this device provides information to facilitate rendering an accurate diagnosis of AS. Patient management decisions should not be made solely on the results of the EchoSolv AS analysis. EchoSolv AS includes both the algorithm based AS phenotype analysis, and the application of recognized Aortic Stenosis clinical practice guidelines. Limitations: EchoSolv AS is not intended for patients under the age of 18 years or those who have previously undergone aortic valve replacement surgery.
Public source Exact FDA submission Checked 2026-09-01
Exact-submission indication text from the ACR AI Central model card. FDA labeling remains controlling.
US images or data. Inclusion criteria: Patients 18 years or older who have an echocardiogram performed as part of routine clinical care (i.e., for the evaluation of structural heart disease). Input includes basic patient demographic data (age, body surface area, height, weight) and measurements obtained from a transthoracic echocardiogram (TTE), including AV Peak Velocity, AV Mean Gradient, AV Area, and other echocardiographic measurements.
Public source Exact FDA submission Checked 2026-09-01
Conservative normalization of explicit wording in an exact-submission source.
The software provides two assessments: (1) Severe AS Phenotype Probability - a categorical output of high, medium, or low probability of exhibiting a Severe AS phenotype based on the AI algorithm predicting whether AVA is <=1.0 cm²; (2) Severe AS Guideline Assessment - whether the patient meets the definition for Severe AS based on direct evaluation of echocardiogram measurements (AV Peak Velocity, AV Mean Gradient, AV Area) against 2020 ACC/AHA guidelines.
Public source Exact FDA submission Checked 2026-09-01
Clinical output reported in the exact-submission ACR model card.
Needs research Exact FDA submission Checked 2026-08-31
Confirm contraindications, unsupported populations, scanners, protocols, and known failure modes.
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
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.
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.
Vendor confirmation Exact FDA submission Checked 2026-08-13
FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
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.
Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
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
Stand-alone performance and reader study (ACR AI Central category) · Adult
exact submission · Tested version: Exact product version not reported; regulatory study summarized for FDA submission K241245 · n=6268 · Independence not established
K241245
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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 2026-08-13
FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-08-31
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
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 2026-09-02
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
Verify limitations: Confirm contraindications, unsupported populations, scanners, protocols, and known failure modes.
Verify security and privacy controls: FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Verify pricing and total cost: FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Verify recalls and postmarket safety signals: 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.
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-02Last searched
18Fields reviewed
6Source classes checked
0Unreviewed PubMed leads
0Unreviewed 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. 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, pubmed, clinical trials, openfda device recall
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