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
Us2.v1
eko.ai Pte. Ltd. d/b/a Us2.ai
Authorized purpose: Us2.v1 is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, automatically producing a full report with measurements of several key cardiac structural and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists or licensed primary care providers for clinical decision-making. Us2.v1 is indicated for use in adult patients. Us2.v1 has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g. tumors, thrombi). Please note the following limitations: -Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality. -Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions. -If no gender is present, female referenced guideline values will be used for conclusions. -If Body surface area (BSA) is not present, indexed values cannot be provided. -During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of electrocardiogram capture may lead to lower accuracy of the software.
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: Us2.v1 is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, automatically producing a full report with measurements of several key cardiac structural and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists or licensed primary care providers for clinical decision-making. Us2.v1 is indicated for use in adult patients. Us2.v1 has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g. tumors, thrombi). Please note the following limitations: -Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality. -Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions. -If no gender is present, female referenced guideline values will be used for conclusions. -If Body surface area (BSA) is not present, indexed values cannot be provided. -During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of electrocardiogram capture may lead to lower accuracy of the software.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Us2.v1 is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, automatically producing a full report with measurements of several key cardiac structural and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists or licensed primary care providers for clinical decision-making. Us2.v1 is indicated for use in adult patients. Us2.v1 has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g. tumors, thrombi). Please note the following limitations: -Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality. -Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions. -If no gender is present, female referenced guideline values will be used for conclusions. -If Body surface area (BSA) is not present, indexed values cannot be provided. -During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of electrocardiogram capture may lead to lower accuracy of the software.
- Which images or clinical context are in scope? Modality: Ultrasound Anatomy or clinical context: Heart/Cardiovascular Input: Ultrasound images or data involving Heart/Cardiovascular; consult the FDA labeling for exact protocol, series, and quality requirements.
- Who uses it? Intended users: sonographers
- What does the software produce? Output: The software provides an interface for a skilled sonographer to perform the necessary markup on the echocardiographic image prior to review by the prescribing physician. The markup includes: the cardiac segments captured, measurements of distance, time, area and blood flow, quantitative analysis of cardiac function, and a summary report.
- What is its most important limitation? Key limitation: Us2.v1 has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g. tumours, thrombi). Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality. Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions. If no gender is present, female referenced guideline values will be used for conclusions. If Body Surface Area (BSA) is not present, indexed values cannot be provided. During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of electrocardiogram capture may lead to lower accuracy of the software.
Clinical takeaway
Clinical role: Us2.v1 is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, automatically producing a full report with measurements of several key cardiac structural and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists or licensed primary care providers for clinical decision-making. Us2.v1 is indicated for use in adult patients. Us2.v1 has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g. tumors, thrombi). Please note the following limitations: -Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality. -Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions. -If no gender is present, female referenced guideline values will be used for conclusions. -If Body surface area (BSA) is not present, indexed values cannot be provided. -During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of electrocardiogram capture may lead to lower accuracy of the software.
Evidence takeaway
Evidence from the reviewed source record: Study type: Stand-Alone Performance. Cases: 600
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
- Us2.v1 is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, automatically producing a full report with measurements of several key cardiac structural and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists or licensed primary care providers for clinical decision-making. Us2.v1 is indicated for use in adult patients. Us2.v1 has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g. tumors, thrombi). Please note the following limitations: -Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality. -Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions. -If no gender is present, female referenced guideline values will be used for conclusions. -If Body surface area (BSA) is not present, indexed values cannot be provided. -During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of electrocardiogram capture may lead to lower accuracy of the software.
- Intended users
- sonographers
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Care setting and population
- Adult
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Measurement or quantification
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- Ultrasound images or data involving Heart/Cardiovascular; consult the FDA labeling for exact protocol, series, and quality requirements.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Output and human action
- The software provides an interface for a skilled sonographer to perform the necessary markup on the echocardiographic image prior to review by the prescribing physician. The markup includes: the cardiac segments captured, measurements of distance, time, area and blood flow, quantitative analysis of cardiac function, and a summary report.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Limitations
- Us2.v1 has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g. tumours, thrombi). Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality. Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions. If no gender is present, female referenced guideline values will be used for conclusions. If Body Surface Area (BSA) is not present, indexed values cannot be provided. During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of electrocardiogram capture may lead to lower accuracy of the software.
The replacement uses the packet's direct disease-scope, image-quality, clinical-review, data-availability, and acquisition limitations.
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
- K210791
- Modality
- Ultrasound
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Anatomy
- Heart/Cardiovascular
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Clearance type
- 510(k)
- Decision date
- 2021-07-27
- FDA status
- FDA-cleared
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The exact-submission ACR model card explicitly references DICOM in the described input, output, or workflow; exact interfaces, versions, and local compatibility require confirmation.
Interoperability terms explicitly reported in the exact-submission ACR model card; interface versions and local compatibility still require confirmation.
- Deployment and data flow
- On-premise
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.
Supported acquisition environment
Scanner manufacturers: All
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Us2.v1; 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
- Study type: Stand-Alone Performance. Cases: 600
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- 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.
Us2.v1 regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K210791
- Samplen=600
- IndependenceIndependence not established
K210791
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 K210791 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 K210791. 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 K210791 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
25Fields reviewed
10Source classes checked
20Screened PubMed leads
10Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains 20 PubMed and 10 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 20 PubMed and 10 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, fda decision summary packet, 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
-
FDA K210791: Us2.v1
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, evidenceSummary, limitations
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
Us2.v1 model card (K210791)
Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K210791
Scope: postmarketSafety
Research history
-
K210791 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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