Radiology AI Directory

FDA-cleared profile

HealthCCSng

Nano-X AI Ltd.

Authorized purpose: Non-invasive post-processing of routine non-gated, non-contrast CT studies containing the entire heart in adults aged 30 to 85 to evaluate coronary calcified plaque and estimate coronary calcium score and category.

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: Non-invasive post-processing of routine non-gated, non-contrast CT studies containing the entire heart in adults aged 30 to 85 to evaluate coronary calcified plaque and estimate coronary calcium score and category.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Non-invasive post-processing of routine non-gated, non-contrast CT studies containing the entire heart in adults aged 30 to 85 to evaluate coronary calcified plaque and estimate coronary calcium score and category.

Evidence takeaway

Evidence from the reviewed source record: FDA retrospective simulated-use standalone testing used a validation dataset of 436 cases from four healthcare institutions, with algorithm results returned for 427 cases (97.94% yield). Ground truth coronary-calcium category was the majority agreement of two of three U.S. board-certified radiologists. Overall categorical agreement was 89.46% (95% CI 86.15%-92.21%), with category agreements of 86.63% Zero, 87.65% Low, 87.36% Medium, and 98.85% High. The estimated score correlated with ground truth at Pearson r=0.959 (95% CI 0.9499-0.9655, p<0.0001).

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
Non-invasive post-processing of routine non-gated, non-contrast CT studies containing the entire heart in adults aged 30 to 85 to evaluate coronary calcified plaque and estimate coronary calcium score and category.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Radiologists and other interpreting clinicians, with further assessment available to cardiologists, general practitioners, or other clinicians.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Inpatient or outpatient CT workflow, including opportunistic use such as lung cancer screening, for adults aged 30 to 85.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Parallel post-processing and coronary-calcium quantification in the standard workflow; results are for clinician review, and final diagnosis and clinical decisions remain independent clinician responsibilities.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Routine non-gated, non-contrast CT studies containing the entire heart in adults aged 30 to 85; DICOM input. The validation data included CT slice thicknesses from 0.5 to 5 mm and four CT manufacturers.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
An estimated coronary calcium score, an estimated category of Zero (0), Low (1-99), Medium (100-399), or High (>=400), representative axial images with calcified areas annotated for non-zero results, and status or error outputs for non-compliant, no-category, or failed studies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Results are informational and not intended as a stand-alone basis for risk attribution or clinical decision-making. The clinician must review the CT independently; the packet notes that calcium scoring on non-gated CT is less accurate than on gated CT. Input validation can produce non-compliant, no-category, or failure outcomes.
  • 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
K241440
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Heart and coronary arteries
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-08-19
  • 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
Receives DICOM studies from a storage or hosting application such as the Nanox Imaging Analytics Platform or another platform, validates the input, and returns successful analysis results to the hosting application; the packet does not establish every local interface or deployment model.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
On-premise
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

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 HealthCCSng; 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 retrospective simulated-use standalone testing used a validation dataset of 436 cases from four healthcare institutions, with algorithm results returned for 427 cases (97.94% yield). Ground truth coronary-calcium category was the majority agreement of two of three U.S. board-certified radiologists. Overall categorical agreement was 89.46% (95% CI 86.15%-92.21%), with category agreements of 86.63% Zero, 87.65% Low, 87.36% Medium, and 98.85% High. The estimated score correlated with ground truth at Pearson r=0.959 (95% CI 0.9499-0.9655, p<0.0001).
  • 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.

HealthCCSng regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested version2
  • Samplen=400
  • IndependenceIndependence not established

K241440

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 K241440 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 K241440. 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
23Fields 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 K241440: HealthCCSng

    U.S. Food and Drug Administration - Published 2024-08-19 - 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. HealthCCSng model card (K241440)

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

    Scope: intendedUsers, careSetting, 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 K241440

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

    Scope: postmarketSafety

Research history

  1. K241440 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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