Release and scope verification
Map installed build, options, population, anatomy, inputs, outputs, and enabled functions to K233676.
exact submission · checked 2026-09-04FDA-cleared profile
Us2.v2
Eko.ai Pte. Ltd d/b/a Us2.ai
Authorized purpose: Us2.v2 processes acquired transthoracic cardiac ultrasound images to provide automated estimates and measurements of atrial and ventricular dimensions, volumes, and systolic and diastolic function.
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.v2 processes acquired transthoracic cardiac ultrasound images to provide automated estimates and measurements of atrial and ventricular dimensions, volumes, and systolic and diastolic function.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Us2.v2 processes acquired transthoracic cardiac ultrasound images to provide automated estimates and measurements of atrial and ventricular dimensions, volumes, and systolic and diastolic function.
- Which images or clinical context are in scope? Modality: Ultrasound Anatomy or clinical context: Adult heart; atrial and ventricular structures and function Input: DICOM transthoracic echocardiography images using supported B-mode, M-mode, pulsed-wave, continuous-wave, and tissue-Doppler acquisitions.
- Who uses it? Intended users: Qualified cardiologists, sonographers, and licensed professional healthcare practitioners.
- What does the software produce? Output: Automated annotations, atrial and ventricular dimensions and volumes, systolic and diastolic function measurements, and reports for user review.
- What is its most important limitation? Key limitation: Poor image capture can produce poor annotations and measurements. The FDA labeling states that female guidelines are used without gender-specific processing, body-surface-area indexed values are not provided, and inappropriate probes, settings, or absent ECG can reduce accuracy.
Clinical takeaway
Clinical role: Us2.v2 processes acquired transthoracic cardiac ultrasound images to provide automated estimates and measurements of atrial and ventricular dimensions, volumes, and systolic and diastolic function.
Evidence takeaway
Evidence from the reviewed source record: K233676 FDA decision material establishes the labeled use, workflow, inputs, outputs, and limitations for Us2.v2 V2.0.0. No exact-submission clinical performance metric is promoted without a complete source table and version-scoped endpoint.
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.v2 processes acquired transthoracic cardiac ultrasound images to provide automated estimates and measurements of atrial and ventricular dimensions, volumes, and systolic and diastolic function.
- Intended users
- Qualified cardiologists, sonographers, and licensed professional healthcare practitioners.
- Care setting and population
- Adult echocardiography and cardiac ultrasound clinical settings.
- Workflow role
- Automated cardiac-image annotation, measurement, calculation, and reporting support.
- Required input
- DICOM transthoracic echocardiography images using supported B-mode, M-mode, pulsed-wave, continuous-wave, and tissue-Doppler acquisitions.
- Output and human action
- Automated annotations, atrial and ventricular dimensions and volumes, systolic and diastolic function measurements, and reports for user review.
- Limitations
- Poor image capture can produce poor annotations and measurements. The FDA labeling states that female guidelines are used without gender-specific processing, body-surface-area indexed values are not provided, and inappropriate probes, settings, or absent ECG can reduce accuracy.
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
- The FDA package describes DICOM echocardiography input and patient-record management and reporting functions.
- Deployment and data flow
- Not established in reviewed sources
The exact FDA decision material does not establish complete deployment topology, hosting responsibility, availability, upgrade, or service boundaries.
- Security and privacy
- Not established in reviewed sources
Public materials reviewed for this exact submission do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
- Training and support
- Use by qualified cardiologists, sonographers, and licensed professional healthcare practitioners. Follow the exact labeling, local training, supervision, and escalation requirements.
- Monitoring and change control
- Monitor labeled population, acquisition quality, exclusions, reviewer overrides, failures, and downstream workflow effects for K233676.
Deployment boundary
The exact public deployment boundary is incomplete; confirm hosting, data flow, availability, upgrades, security, service, and downtime locally.
exact submission · checked 2026-09-04Interoperability acceptance
The FDA package describes DICOM echocardiography input and patient-record management and reporting functions.
exact submission · checked 2026-09-04Clinical acceptance
Test labeled population, acquisition quality, exclusions, failed inputs, reviewer overrides, and downstream effects for K233676.
exact submission · checked 2026-09-04Economic evaluation
Exact-product price, implementation cost, reimbursement, and total-cost evidence remain to be obtained; do not infer them from FDA clearance.
product family · checked 2026-09-04Lifecycle monitoring
Monitor labeling, software version, complaints, recalls, failed inputs, overrides, and postmarket signals against the exact submission and installed configuration.
exact submission · checked 2026-09-04Evidence
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
- K233676 FDA decision material establishes the labeled use, workflow, inputs, outputs, and limitations for Us2.v2 V2.0.0. No exact-submission clinical performance metric is promoted without a complete source table and version-scoped endpoint.
- Reported sensitivity
- Not applicable
Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.
- Reported specificity
- Not applicable
Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K233676 FDA evidence package for Us2.v2
- DesignFDA 510(k) decision evidence and product verification for the exact submission.
- PopulationAdult heart; atrial and ventricular structures and function
- Scopeexact submission
- Tested versionUs2.v2 V2.0.0
- IndependenceSponsor or vendor study
K233676
FDA-submitted evidence for the exact decision; it is not independent clinical validation and does not establish local production qualification.
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
- Not established in reviewed sources
No public list price or commercial contract for the exact submission and version was identified.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer coverage or reimbursement determination was identified in reviewed public material.
No product-specific code
No exact-product reimbursement determination identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesThis public-policy review is not a coverage determination. Verify payer, site-of-service, coding, and local value assumptions independently.
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
- No record matched K233676 by exact native submission identifier in the 2026-09-02 openFDA snapshot; this does not exclude product-family, later-version, or adverse-event information.
Buyer worksheet
Open questions to take to the vendor
- Verify deployment and data flow: The exact FDA decision material does not establish complete deployment topology, hosting responsibility, availability, upgrade, or service boundaries.
- Verify security and privacy controls: Public materials reviewed for this exact submission do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
- Verify pricing and total cost: No public list price or commercial contract for the exact submission and version was identified.
- Verify reimbursement and coding relevance: No exact-product payer coverage or reimbursement determination was identified in reviewed public material.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-04Last searched
27Fields reviewed
11Source classes checked
20Screened PubMed leads
10Screened trial leads
0Unreviewed FDA recall leads
No evidence was promoted. PMID 40876740 explicitly uses Us2.ai version 1.4.5 rather than Us2.v2 V2.0.0; other Us2.ai records omit a tested version, and the remaining alias and trial records are unrelated. 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 decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, 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 510(k) decision material K233676: Us2.v2
Scope: identity, submission_linkage, modality, anatomy, clinical_use, intended_users, care_setting, workflow_role, input, output, limitations, evidence
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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Us2.v2 model card (K233676)
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
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Medicare Coverage Database
Scope: coverage, codingContext
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openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
Research history
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K233676 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
human reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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