Radiology AI Directory

FDA-cleared profile

CT VScore+

Canon Medical Informatics, Inc.

CT VScore+ evaluates calcified coronary lesions on ECG-gated, non-contrast cardiac CT in patients aged 30 years or older, automatically generating coronary calcium scores and highlighted calcium segmentation for qualified clinical review.

Cardiac imagingQuantification and segmentation
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.

Clinical fit

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
CT VScore+ evaluates calcified coronary lesions on ECG-gated, non-contrast cardiac CT in patients aged 30 years or older, automatically generating coronary calcium scores and highlighted calcium segmentation for qualified clinical review.
FDA source Exact FDA submission Checked 2026-09-07
Intended users
Qualified healthcare professionals reviewing cardiac CT; the FDA summary describes user editing of automated segmentation but does not establish a broader credentialing program.
FDA source Exact FDA submission Checked 2026-09-07
Care setting and population
Cardiac CT, cardiology, or radiology workflow on the Vitrea platform.
FDA source Exact FDA submission Checked 2026-09-07
Workflow role
Coronary calcium scoring and supplementary calcium segmentation for clinical risk-context reporting; the segmentation map and 3D view are not stand-alone diagnostic outputs.
FDA source Exact FDA submission Checked 2026-09-07
Required input
ECG-gated, non-contrast cardiac CT DICOM images for patients aged 30 years or older.
FDA source Exact FDA submission Checked 2026-09-07
Output and human action
Agatston and volume scores for combined LM+LAD, RCA, and LCX; highlighted calcium segmentation; optional MESA and Hoff-Kondos reference context; DICOM image and DICOM Structured Report export.
FDA source Exact FDA submission Checked 2026-09-07
Limitations
The automated output combines LM+LAD; separate LM and LAD results require manual segmentation. The segmentation map is informational, the 3D Calcium View is supplementary, and the FDA validation observed nonzero assignments in 9 of 50 confirmed zero-calcium cases, so low scores require physician review.
FDA source Exact FDA submission Checked 2026-09-07

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
K252217
FDA source Exact FDA submission Checked 2026-08-31
Modality
CT/CTA
FDA source Exact FDA submission Checked 2026-09-07
Anatomy
Heart/Cardiovascular
FDA source Exact FDA submission Checked 2026-09-07
Clearance type
510(k)
FDA source Exact FDA submission Checked 2026-08-31
Decision date
2025-11-28
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
The software runs on Vitrea, processes DICOM, and can export results to DICOM-capable image management, archival, or reporting systems and as DICOM SR; site-specific interface and routing compatibility require testing.
FDA source Exact FDA submission Checked 2026-09-07
Deployment and data flow
Vitrea platform deployment is established by the FDA summary; public material reviewed does not establish the exact site hosting topology, infrastructure prerequisites, retention, availability, or service boundary for K252217.
FDA source Exact FDA submission Checked 2026-09-07
Security and privacy
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-07

The reviewed exact FDA packet and Canon product page do not establish current scoped security controls, certification scope, PHI flow, retention, access control, audit, or incident response.

Training and support
Use requires qualified clinical review of automated scores and segmentation; local onboarding should cover the exact CT protocol, manual LM/LAD assignment, low-score limitations, export behavior, and escalation.
FDA source Exact FDA submission Checked 2026-09-07
Monitoring and change control
Monitor protocol acceptance, score and segmentation edits, low-score false-positive behavior, DICOM/SR delivery, failed or repeated analyses, reader overrides, downtime, updates, complaints, and recalls by exact K252217 build.
FDA source Exact FDA submission Checked 2026-09-07

Buyer acceptance guidance derived from the exact intended inputs, outputs, and validation limitations; it is not a claimed vendor monitoring service.

Vitrea platform dependency

The exact submission runs on the Vitrea platform and processes eligible ECG-gated non-contrast cardiac CT DICOM images.

exact submission · checked 2026-09-07
Source

DICOM and structured reporting

Results can be exported to DICOM-capable image management, archive, or reporting systems and saved as DICOM SR; validate local routing, identifiers, and report ingestion.

exact submission · checked 2026-09-07
Source

Current Canon workflow

Canon describes CT VScore+ as automating routine coronary calcium scoring for in-house cardiac CT operations, with structured data export through the Export+ add-on.

product family · checked 2026-09-07

Current family page context; it does not establish that the K252217 release includes every current add-on or workflow feature.

Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.

Evidence summary
K252217 FDA evidence is a regulatory agreement and segmentation-validation package for CT VScore+; no independent clinical outcomes or comparative paper were promoted in this timeboxed review.
FDA source Exact FDA submission Checked 2026-09-07
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.

Total Agatston Score ICC

0.997 ICC

Agreement with reference total Agatston score in 236 independent pivotal validation cases from diverse U.S. sites and scanner vendors.

Tested version: CT VScore+ as described in K252217
Source

CAC-DRS four-class kappa

0.959 Cohen kappa

Agreement for four-class CAC-DRS risk classification in 236 independent pivotal validation cases.

Tested version: CT VScore+ as described in K252217
Source

Zero-calcium cases assigned nonzero

18 percent

Confirmed zero-calcium cases assigned a nonzero score in Confirmed zero-calcium cases in the pivotal validation set.

Tested version: CT VScore+ as described in K252217
Source

K252217 development and pivotal validation for CT VScore+

Retrospective regulatory performance validation with separate development and pivotal datasets; three U.S. board-certified physicians reviewed validation cases. · Patients aged 30 years or older with eligible ECG-gated non-contrast cardiac CT

exact submission · Tested version: CT VScore+ configuration described in K252217 · n=236 · Sponsor or vendor study

K252217

Manufacturer-submitted FDA evidence; it is not independent clinical-outcome validation.

Source

Economics and lifecycle

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-07

No public list price for the exact K252217 configuration was established in the reviewed official sources; obtain a quote separating license, Vitrea platform, Export+ add-ons, implementation, interfaces, support, and upgrades.

Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-09-07

Payer-policy review was not applied to this non-plaque-specific dossier; no product-specific coverage determination is made.

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 wave22 exact-submission recall query returned no native recall record for K252217. This does not establish absence of family, later-version, or adverse-event information.
Public source Exact FDA submission Checked 2026-09-07

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.

Human reviewedStatus
2026-09-07Last searched
24Fields reviewed
11Source classes checked
0Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads

The stored PubMed and ClinicalTrials.gov candidate arrays were screened and were empty. No paper or trial was promoted; empty stored arrays do not establish that no external literature or trials exist. 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, vendor product page, fda device recall, literature index, trial registry, stored candidate metadata, pubmed, clinical trials, openfda device recall

Sources

Source ledger

Sources accessed through 2026-09-07.

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