Deployment model
On-premises deployment is explicitly described in the exact-submission ACR model card; hosting region, data flow, and current commercial configuration require vendor confirmation.
exact submission · checked 2026-09-01FDA-cleared profile
AVIEW CAC
Coreline Soft Co., Ltd.
Authorized purpose: Provides quantitative coronary-plaque analysis using Agatston scoring, RCA/LCA segmentation, and calcium-score, gender, and age percentile risk stratification.
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: Provides quantitative coronary-plaque analysis using Agatston scoring, RCA/LCA segmentation, and calcium-score, gender, and age percentile risk stratification.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Provides quantitative coronary-plaque analysis using Agatston scoring, RCA/LCA segmentation, and calcium-score, gender, and age percentile risk stratification.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Heart and coronary arteries Input: Existing DICOM 3.0 non-contrast, non-gated chest CT from specified GE or GE-subsidiary acquisitions in adults over 40 years.
- Who uses it? Intended users: Healthcare professionals, including radiologists and cardiologists.
- What does the software produce? Output: Agatston score, RCA/LCA evaluation, and percentile risk categories.
- What is its most important limitation? Key limitation: Other CT manufacturers were not validated or recommended.
Clinical takeaway
Clinical role: Provides quantitative coronary-plaque analysis using Agatston scoring, RCA/LCA segmentation, and calcium-score, gender, and age percentile risk stratification.
Evidence takeaway
Evidence from the reviewed source record: No clinical study was necessary; nonclinical testing used 150 gated and 150 non-gated cases, with ICC versus ground truth of 0.896 total, 0.927 LCA, and 0.840 RCA.
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
- Provides quantitative coronary-plaque analysis using Agatston scoring, RCA/LCA segmentation, and calcium-score, gender, and age percentile risk stratification.
Clinical-use display mirrors the exact FDA-supported purpose reconciled in this remediation finding.
- Intended users
- Healthcare professionals, including radiologists and cardiologists.
FDA packet user statement.
- Care setting and population
- Adult
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Segmentation or contouring
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- Existing DICOM 3.0 non-contrast, non-gated chest CT from specified GE or GE-subsidiary acquisitions in adults over 40 years.
Exact FDA input and compatibility scope.
- Output and human action
- Agatston score, RCA/LCA evaluation, and percentile risk categories.
FDA output description.
- Limitations
- Other CT manufacturers were not validated or recommended.
Exact FDA compatibility boundary.
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
- K233211
- Modality
- CT/CTA
FDA non-contrast chest CT normalized to the controlled CT/CTA bucket; CTA is not implied.
- Anatomy
- Heart and coronary arteries
Exact FDA anatomy scope.
- Clearance type
- 510(k)
- Decision date
- 2024-03-29
- FDA status
- FDA-cleared
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
- Deployment and data flow
- On-premises deployment is explicitly described in the exact-submission ACR model card; hosting region, data flow, and current commercial configuration require vendor confirmation.
Deployment mode explicitly reported in the exact-submission ACR model card; hosting region and current commercial configuration still require vendor confirmation.
- Security and privacy
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Supported acquisition environment
Scanner manufacturers: GE
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for AVIEW CAC; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-09Evidence
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 clinical study was necessary; nonclinical testing used 150 gated and 150 non-gated cases, with ICC versus ground truth of 0.896 total, 0.927 LCA, and 0.840 RCA.
FDA packet evidence summary.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
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.
AVIEW CAC regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K233211
- Samplen=300
- IndependenceIndependence not established
K233211
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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
No public price or quote for the exact K233211 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
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 K233211. 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.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K233211 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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
25Fields reviewed
10Source 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, 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
-
FDA K233211: AVIEW CAC
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
AVIEW CAC model card (K233211)
Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, deployment, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K233211
Scope: postmarketSafety
Research history
-
K233211 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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