GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
AutoAS is a software application intended to assist medical professionals in the assessment of moderate/severe aortic stenosis (AS). The software uses an artificial intelligence (AI) algorithm to process previously acquired two-dimensional transthoracic echocardiography (2D-TTE) images to provide a suggestion of moderate/severe aortic stenosis along with an associated confidence metric that can be a diagnostic aid to a physician in a point of care or similar setting in determining if further evaluation is needed, including whether a full echocardiogram (2D, Doppler) needs to be performed. The results of AutoAS are not intended to be used on a stand-alone basis for clinical decision making and are not intended to supplement or replace a full echocardiographic examination. AutoAS results, along with the obtained ultrasound images, must be reviewed by a qualified physician. The AutoAS product is not intended to be used on patients who have prosthetic valves and/or have had prior valve repair or replacement. AutoAS software is indicated for use in adult patients and is intended to be an accessory to compatible ultrasound systems in environments where healthcare is provided.
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
AutoAS is a software application intended to assist medical professionals in the assessment of moderate/severe aortic stenosis (AS). The software uses an artificial intelligence (AI) algorithm to process previously acquired two-dimensional transthoracic echocardiography (2D-TTE) images to provide a suggestion of moderate/severe aortic stenosis along with an associated confidence metric that can be a diagnostic aid to a physician in a point of care or similar setting in determining if further evaluation is needed, including whether a full echocardiogram (2D, Doppler) needs to be performed. The results of AutoAS are not intended to be used on a stand-alone basis for clinical decision making and are not intended to supplement or replace a full echocardiographic examination. AutoAS results, along with the obtained ultrasound images, must be reviewed by a qualified physician. The AutoAS product is not intended to be used on patients who have prosthetic valves and/or have had prior valve repair or replacement. AutoAS software is indicated for use in adult patients and is intended to be an accessory to compatible ultrasound systems in environments where healthcare is provided.
Public source Exact FDA submission Checked 2026-09-01
Exact-submission indication text from the ACR AI Central model card. FDA labeling remains controlling.
Qualified physician with training and experience in cardiac ultrasound and echocardiographic interpretation; medical professionals in a point of care or similar setting
Public source Exact FDA submission Checked 2026-09-01
Intended-user text reported in the exact-submission ACR model card.
US images or data. Inclusion criteria: Adult patients undergoing transthoracic cardiac ultrasound examinations in whom assessment for aortic stenosis (AS) is clinically relevant; patients being evaluated for the presence or likelihood of moderate to severe aortic stenosis as part of a routine or targeted echocardiographic study; B-mode 2D transthoracic echocardiography (2D-TTE) images including PLAX, PSAX-AV, and AP5 views
Public source Exact FDA submission Checked 2026-09-01
Conservative normalization of explicit wording in an exact-submission source.
The AI model outputs a two-level (binary) severity prediction: 1) Suggestive of moderate to severe AS, or 2) Not suggestive of moderate to severe AS, along with an associated confidence metric/score indicating the algorithm's certainty in its prediction. Results are summarized in a report available after the exam for physician review.
Public source Exact FDA submission Checked 2026-09-01
Clinical output reported in the exact-submission ACR model card.
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
K254161
FDA source Exact FDA submission Checked 2026-08-31
Needs research Exact FDA submission Checked 2026-08-31
Attach an exact-product deployment and data-flow source.
Security and privacy
Vendor documentation pending
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.
Automated Aortic Stenosis Software (AutoAS) 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 K254161 · n=401 · 4 sites · Independence not established
K254161
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 2026-09-04
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.
Verify deployment and data flow: Attach an exact-product deployment and data-flow source.
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.
Automated sources checkedStatus
2026-09-04Last searched
17Fields reviewed
5Source 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, acr ai central product, pubmed, clinical trials, openfda device recall
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