Radiology AI Directory

FDA-authorized profile

Caption Interpretation Automated Ejection Fraction Software

Caption Health, Inc

Automated estimation of adult left-ventricular ejection fraction from previously acquired transthoracic echocardiography images to assist clinician cardiac evaluation.

Cardiac imagingUltrasound workflow
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

Automated estimation of adult left-ventricular ejection fraction from previously acquired transthoracic echocardiography images to assist clinician cardiac evaluation.

Overview status: Field-derived fact summary This section is assembled from the sourced field records below; it is not a source-reviewed editorial overview.

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
Automated estimation of adult left-ventricular ejection fraction from previously acquired transthoracic echocardiography images to assist clinician cardiac evaluation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Clinicians evaluating adult cardiac function from transthoracic echocardiography.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Care setting and population
Clinical environments where compatible adult transthoracic echocardiography images have already been acquired.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Automated quantitative assistance for left-ventricular ejection-fraction assessment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Previously acquired adult transthoracic echocardiography images meeting the cleared input and image-quality requirements.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Output and human action
An automated left-ventricular ejection-fraction estimate for clinician review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Limitations
The estimate assists cardiac evaluation and does not replace clinician interpretation or other clinical information; performance depends on eligible, adequate-quality echocardiography images.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

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
DEN220063
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Anatomy
Heart/Cardiovascular
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Clearance type
De Novo
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-02-24
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-authorized
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
The exact De Novo summary establishes processing of previously acquired echocardiography images; current device, PACS, and hosting compatibility requires vendor confirmation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Current product-family workflow context

GE HealthCare describes the current Caption AI family as combining guided cardiac image acquisition with automated ejection-fraction estimation on supported ultrasound workflows.

product family · checked 2026-09-08

Confirm exact-release availability, interfaces, hosting, security, support, and commercial terms during procurement.

Source

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
No new performance testing was provided for DEN220063; the packet summarizes prior K210747 testing, including retrospective multicenter validation on 186 patient studies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact De Novo summary states that the current submission added a PCCP and summarizes the prior 186-study validation.

Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

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.

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

No public price or quote for the exact DEN220063 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

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 DEN220063. 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.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-19Last searched
17Fields reviewed
11Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA support assessed on 2026-09-19. Packet-supported facts: purpose, modality, anatomy, intendedUsers, input, output, limitations; packet-unavailable facts: evidenceSummary. Candidate literature and postmarket candidates remain in their existing review state. 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, fda decision summary, fda de novo summary, vendor support page, 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

  1. FDA DEN220063: Caption Interpretation Automated Ejection Fraction Software

    U.S. Food and Drug Administration - Published 2023-02-24 - Accessed 2026-09-19

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  5. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  6. openFDA exact recall query for DEN220063

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

  7. Caption AI on Vscan Air

    GE HealthCare - Accessed 2026-09-08

    Scope: productFamily, clinicalWorkflow, implementationCapabilities

Research history

  1. DEN220063 FDA decision

    Regulatory record

    De Novo

  2. Source-review record updated

    Research record

    fda record reviewed

Alternatives

Related tools to compare

FDA-cleared K260780

HeartFocus

Deski

Guides medical professionals acquiring ten standard 2D transthoracic echocardiographic views in adults requiring a cardiac ultrasound examination; acquired images require...

Modality
Ultrasound
Anatomy
Heart/Cardiovascular
Decision
2026-06-03
Cardiac imagingUltrasound workflow