ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Clarius Ejection Fraction AI; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission ยท checked 2026-09-08FDA-cleared profile
Clarius Ejection Fraction AI
Clarius Mobile Health Corp.
Authorized purpose: Semi-automated measurement of left ventricular ejection fraction during cardiac ultrasound.
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: Semi-automated measurement of left ventricular ejection fraction during cardiac ultrasound.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Semi-automated measurement of left ventricular ejection fraction during cardiac ultrasound.
- Which images or clinical context are in scope? Modality: Ultrasound Anatomy or clinical context: Heart, specifically the left ventricle Input: Ultrasound image data acquired by Clarius phased-array or curvilinear scanners, including PLAX, PSAX, AP4, and AP2 views; the algorithm automatically captures ED/ES frames and is integrated into the Clarius App on iOS/Android.
- Who uses it? Intended users: Healthcare professionals trained and qualified in ultrasound.
- What does the software produce? Output: Semi-automatic LV EF measurement using Simpson single-plane/apical, fractional area change/PSAX, and Teicholz/PLAX methods; segmentation masks or landmark markers identify the LV, ED/ES frames are captured, and the user can manually adjust caliper measurements.
- What is its most important limitation? Key limitation: Adults only; not stand-alone software and limited to the listed Clarius scanner/app ecosystem and cleared transducers. Inadequate-quality images, incomplete anatomy/views, or failure to generate a measurement were excluded from the measurement comparison. The FDA packet also describes a PCCP for future scanner/input and algorithm changes, with data-skew and concept-drift risks requiring verification.
Clinical takeaway
Clinical role: Semi-automated measurement of left ventricular ejection fraction during cardiac ultrasound.
Evidence takeaway
Evidence from the reviewed source record: FDA packet: retrospective clinical verification of 279 exams from a multi-center anonymized dataset, with three expert reviewers and separate clinical design validation in simulated use. The verification excluded inadequate/incomplete images and subjects for which the model failed to generate a measurement; it was a measurement comparison without follow-up clinical examination.
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
- Semi-automated measurement of left ventricular ejection fraction during cardiac ultrasound.
- Intended users
- Healthcare professionals trained and qualified in ultrasound.
- Care setting and population
- Professional healthcare setting such as a hospital or clinic.
- Workflow role
- Assistive real-time/semi-automatic EF measurement during cardiac ultrasound, with clinician adjustment and final responsibility.
- Required input
- Ultrasound image data acquired by Clarius phased-array or curvilinear scanners, including PLAX, PSAX, AP4, and AP2 views; the algorithm automatically captures ED/ES frames and is integrated into the Clarius App on iOS/Android.
- Output and human action
- Semi-automatic LV EF measurement using Simpson single-plane/apical, fractional area change/PSAX, and Teicholz/PLAX methods; segmentation masks or landmark markers identify the LV, ED/ES frames are captured, and the user can manually adjust caliper measurements.
- Limitations
- Adults only; not stand-alone software and limited to the listed Clarius scanner/app ecosystem and cleared transducers. Inadequate-quality images, incomplete anatomy/views, or failure to generate a measurement were excluded from the measurement comparison. The FDA packet also describes a PCCP for future scanner/input and algorithm changes, with data-skew and concept-drift risks requiring verification.
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
- Integrated into the Clarius App and complete Clarius Ultrasound Scanner system, not a stand-alone device; compatible iOS/Android app versions and PA HD3, PAL HD3, and C3 HD3 transducers are listed in the packet. Generic DICOM/PACS integration is not established for the subject device.
- Deployment and data flow
- Vendor documentation pending
The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- 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.
Evidence
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 packet: retrospective clinical verification of 279 exams from a multi-center anonymized dataset, with three expert reviewers and separate clinical design validation in simulated use. The verification excluded inadequate/incomplete images and subjects for which the model failed to generate a measurement; it was a measurement comparison without follow-up clinical examination.
- 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.
Clarius Ejection Fraction AI regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K253593
- Samplen=270
- IndependenceIndependence not established
K253593
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 K253593 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 K253593. 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 deployment and data flow: The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- 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 K253593 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
21Fields 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, acr ai central product, fda decision summary, 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 K253593: Clarius Ejection Fraction AI
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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Clarius Ejection Fraction AI model card (K253593)
Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, anatomy, evidenceStudies
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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
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openFDA exact recall query for K253593
Scope: postmarketSafety
Research history
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K253593 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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