Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
EchoMeasure
iCardio.ai
Authorized purpose: Process previously acquired DICOM-compliant cardiac ultrasound images and make automated cardiac measurements to support qualified cardiologists, sonographers, or other licensed healthcare practitioners in adult clinical decision-making.
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: Process previously acquired DICOM-compliant cardiac ultrasound images and make automated cardiac measurements to support qualified cardiologists, sonographers, or other licensed healthcare practitioners in adult clinical decision-making.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Process previously acquired DICOM-compliant cardiac ultrasound images and make automated cardiac measurements to support qualified cardiologists, sonographers, or other licensed healthcare practitioners in adult clinical decision-making.
- Which images or clinical context are in scope? Modality: Ultrasound Anatomy or clinical context: Heart and cardiovascular structures Input: Previously acquired DICOM-compliant transthoracic cardiac ultrasound images, including appropriate PLAX, A2C, or A4C views with acceptable quality and identifiable end-diastolic and end-systolic frames.
- Who uses it? Intended users: Qualified cardiologists, sonographers, accredited echocardiographers, or other licensed professional healthcare practitioners.
- What does the software produce? Output: Automated measurements of left-ventricular volume and diameter, right-ventricular diameter, posterior-wall thickness, aortic annulus, LV outflow tract, sinus of Valsalva, sinotubular junction, left-atrium dimension, and interventricular septal thickness; results are viewable in a browser interface, report, or PDF and are intended for third-party software or hardware consumption.
- What is its most important limitation? Key limitation: Indicated for adults and qualified clinical users. The output supports review and clinical decision-making and remains subject to clinician confirmation; it is not an independent diagnostic decision. The FDA standalone study used one selected DICOM view per case from GE and Teratech systems, so broader protocol or vendor performance is not established by this packet.
Clinical takeaway
Clinical role: Process previously acquired DICOM-compliant cardiac ultrasound images and make automated cardiac measurements to support qualified cardiologists, sonographers, or other licensed healthcare practitioners in adult clinical decision-making.
Evidence takeaway
Evidence from the reviewed source record: FDA retrospective standalone performance testing used 200 distinct patients from two independent U.S. clinical sites, with one selected DICOM view per case. Ground truth was the mean of three experienced U.S. cardiac sonographers. The study evaluated the bivariate linear regression coefficient slope (BLRSC) against the reference annotations; all predefined limits were met, with listed BLRSC point estimates ranging from 0.773 to 1.112. The FDA summary also describes median absolute error, median percent error, Pearson and Spearman correlation, and Individual Equivalence Coefficient analyses, but does not report sensitivity or specificity. No data from the sites were used for training or tuning.
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
- Process previously acquired DICOM-compliant cardiac ultrasound images and make automated cardiac measurements to support qualified cardiologists, sonographers, or other licensed healthcare practitioners in adult clinical decision-making.
- Intended users
- Qualified cardiologists, sonographers, accredited echocardiographers, or other licensed professional healthcare practitioners.
- Care setting and population
- Adult clinical echocardiography workflow; the FDA packet permits secure cloud-server or on-premise-server deployment but does not name a specific facility type.
- Workflow role
- Post-acquisition image eligibility and quality control followed by automated measurement support; the reviewing clinician can accept, reject, edit, or ignore the output and review the generated report.
- Required input
- Previously acquired DICOM-compliant transthoracic cardiac ultrasound images, including appropriate PLAX, A2C, or A4C views with acceptable quality and identifiable end-diastolic and end-systolic frames.
- Output and human action
- Automated measurements of left-ventricular volume and diameter, right-ventricular diameter, posterior-wall thickness, aortic annulus, LV outflow tract, sinus of Valsalva, sinotubular junction, left-atrium dimension, and interventricular septal thickness; results are viewable in a browser interface, report, or PDF and are intended for third-party software or hardware consumption.
- Limitations
- Indicated for adults and qualified clinical users. The output supports review and clinical decision-making and remains subject to clinician confirmation; it is not an independent diagnostic decision. The FDA standalone study used one selected DICOM view per case from GE and Teratech systems, so broader protocol or vendor performance is not established by this packet.
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.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- Receives DICOM inputs and can be deployed on a secure cloud server or on-premise server; output can be consumed by third-party software or hardware, viewed in a native browser interface, and downloaded as PDF. Specific PACS, RIS, EHR, interface versions, and local compatibility are not established.
- Deployment and data flow
- Both
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
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
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 EchoMeasure; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08Evidence
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 retrospective standalone performance testing used 200 distinct patients from two independent U.S. clinical sites, with one selected DICOM view per case. Ground truth was the mean of three experienced U.S. cardiac sonographers. The study evaluated the bivariate linear regression coefficient slope (BLRSC) against the reference annotations; all predefined limits were met, with listed BLRSC point estimates ranging from 0.773 to 1.112. The FDA summary also describes median absolute error, median percent error, Pearson and Spearman correlation, and Individual Equivalence Coefficient analyses, but does not report sensitivity or specificity. No data from the sites were used for training or tuning.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
This field has not been curated yet.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
EchoMeasure regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K241430
- Samplen=200
- IndependenceIndependence not established
K241430
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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
No public price or quote for the exact K241430 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
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 K241430. 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.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K241430 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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
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
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FDA K241430: EchoMeasure
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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EchoMeasure model card (K241430)
Scope: intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K241430
Scope: postmarketSafety
Research history
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K241430 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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