Radiology AI Directory

FDA-cleared profile

Cardiac CT Function Software Application

Circle Cardiovascular Imaging

Authorized purpose: Assist qualified medical professionals in assessing and evaluating cardiac function from multi-phase, multi-slice cardiovascular CT angiography images.

Cardiac imaging
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: Assist qualified medical professionals in assessing and evaluating cardiac function from multi-phase, multi-slice cardiovascular CT angiography images.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Assist qualified medical professionals in assessing and evaluating cardiac function from multi-phase, multi-slice cardiovascular CT angiography images.

Evidence takeaway

Evidence from the reviewed source record: FDA K241038 states that no clinical studies were necessary for substantial equivalence. ML validation used data from 9 sites, with 90% sampled from US sources and validation data separated from development data; reference standards used three expert readers. Reported segmentation endpoints were LV cavity MAE <10%, Dice >86%, Hausdorff distance <9.5 mm, and EF bias 1.3% (95% CI -12 to 14); RV cavity MAE <18%, Dice >85%, Hausdorff distance <18 mm, and EF bias -5.5% (95% CI -15 to 4.4); LV myocardium MAE <17%, Dice >82%, and Hausdorff distance <15 mm.

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
Assist qualified medical professionals in assessing and evaluating cardiac function from multi-phase, multi-slice cardiovascular CT angiography images.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Qualified medical professionals, including physicians, cardiologists, and radiologists
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Standard-of-care cardiovascular CT analysis workflow; facility type is not stated in the FDA packet
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Post-processing cardiac-function analysis with editable LV cavity, LV myocardium, and RV cavity surfaces; users review and correct automated results or perform segmentation manually before measurement.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Multi-phase, multi-slice cardiovascular CT angiography images in DICOM Standard format; the comparison table describes vendor-independent cardiac CTA input.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Manual or semi-automatic segmentation of LV cavity, LV myocardium, and RV cavity, with EDV, ESV, SV, EF, CO, CI, EDM, ESM, and EDESM displayed on screen and in a CT Function Report; MPR and 3D views are also described.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
The application is an aid to the existing standard of care and does not replace existing physician software. All generated surfaces are editable and users are advised to verify and correct errors; manual segmentation is available. The packet does not establish use outside the specified multi-phase cardiovascular CTA input or autonomous clinical decision-making.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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
K241038
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Heart and cardiovascular structures
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-06-07
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • 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
DICOM Standard input, on-screen results, and saved results for future review are established. The packet states that the module does not interface directly with data-collection equipment and that functionality depends on the acquisition vendor; a specific PACS, RIS, EHR, or deployment configuration is not established.
  • 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.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Cardiac CT Function Software Application; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-08
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
FDA K241038 states that no clinical studies were necessary for substantial equivalence. ML validation used data from 9 sites, with 90% sampled from US sources and validation data separated from development data; reference standards used three expert readers. Reported segmentation endpoints were LV cavity MAE <10%, Dice >86%, Hausdorff distance <9.5 mm, and EF bias 1.3% (95% CI -12 to 14); RV cavity MAE <18%, Dice >85%, Hausdorff distance <18 mm, and EF bias -5.5% (95% CI -15 to 4.4); LV myocardium MAE <17%, Dice >82%, and Hausdorff distance <15 mm.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
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.

Cardiac CT Function Software Application regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K241038
  • Sites9
  • IndependenceIndependence not established

K241038

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

Source

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 K241038 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 K241038. 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
2026-09-20Last searched
20Fields 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

  1. FDA K241038: Cardiac CT Function Software Application

    U.S. Food and Drug Administration - Published 2024-06-07 - Accessed 2026-09-08

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Cardiac CT Function Software Application model card (K241038)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

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

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

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

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K241038

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

    Scope: postmarketSafety

Research history

  1. K241038 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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