Radiology AI Directory

FDA-cleared profile

CT Cardiomegaly

Innolitics, LLC

Automatically calculate linear and area-based cardiothoracic ratio from a CT study containing the heart to support clinician assessment of possible cardiomegaly; not for standalone clinical decision-making or diagnosis.

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.

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
Automatically calculate linear and area-based cardiothoracic ratio from a CT study containing the heart to support clinician assessment of possible cardiomegaly; not for standalone clinical decision-making or diagnosis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Physicians or other licensed practitioners in clinics, hospitals, healthcare facilities, residential care facilities, and long-term care services.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Clinics, hospitals, healthcare facilities, residential care facilities, and long-term care services.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Automated heart and chest segmentation and CTR measurement; can run standalone or as part of another medical device, with clinician review of the summary report and all available information.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
A CT image study containing the heart; the software selects an axial slice containing the heart if present. The labeled population is adults and transitional adolescents aged 18-21 treated as adults.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
PDF and JSON summary reports containing linear-based CTR, area-based CTR or Heart to Chest Area Ratio, heart-area and inner-chest-area segmentations, patient information, and user-specified reference values.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Results are not intended as the primary input for clinical decision-making or diagnosis and do not replace clinical assessment. The indication is limited to adults and transitional adolescents aged 18-21 treated as adults and to CT studies containing the heart; the FDA packet does not establish DICOM/PACS output or a clinical-disease detection claim.
  • 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
K232613
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Heart and thoracic cavity (cardiothoracic ratio)
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-02-28
  • 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
Command-line software that may run standalone or as part of another medical device and writes PDF and JSON reports. The FDA packet does not establish a PACS, DICOM, RIS, EHR, or other specific external interface.
  • 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.

ACR exact-submission catalog context

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

exact submission ยท 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 K232613 reports technical performance against measurements from three board-certified radiologists. The testing set contained 275 unique patients from sites across 12 US states, aged 18-96 years, with varied scanners, protocols, contrast status, and CT types. Mean absolute difference was 0.009 for both CTR endpoints; 95% limits of agreement were [-0.033, 0.035] for CTR and [-0.028, 0.035] for Heart to Chest Area Ratio. Key-slice-position mean difference was 0.46 mm, and heart segmentation Dice was 0.95 (95% CI 0.950-0.956).
  • 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.

CT Cardiomegaly regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K232613
  • Samplen=275
  • IndependenceIndependence not established

K232613

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 K232613 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 K232613. 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
2026-09-08Last searched
20Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. 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, 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 K232613: CT Cardiomegaly

    U.S. Food and Drug Administration - Published 2024-02-28 - 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. CT Cardiomegaly model card (K232613)

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

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

  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 K232613

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

    Scope: postmarketSafety

Research history

  1. K232613 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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