Authorized purpose: CaRi-Plaque is a web-based post-processing tool for trained operators and healthcare professionals that analyzes previously acquired CCTA DICOM data for coronary plaque characteristics, plaque burden, luminal stenosis, and related vessel measurements.
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: CaRi-Plaque is a web-based post-processing tool for trained operators and healthcare professionals that analyzes previously acquired CCTA DICOM data for coronary plaque characteristics, plaque burden, luminal stenosis, and related vessel measurements.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: CaRi-Plaque is a web-based post-processing tool for trained operators and healthcare professionals that analyzes previously acquired CCTA DICOM data for coronary plaque characteristics, plaque burden, luminal stenosis, and related vessel measurements.
Which images or clinical context are in scope?Modality: CT/CTA Anatomy or clinical context: Heart/Cardiovascular Input: Previously acquired adult CCTA DICOM data sent through a secure PACS or local hard drive for processing.
Who uses it?Intended users: Trained internal operators and healthcare professionals reviewing adult CCTA-derived plaque analysis; the report supports but does not replace clinical judgment.
What does the software produce?Output: Maximum stenosis; total, calcified, non-calcified, and low-density non-calcified plaque volumes; plaque burden; remodeling index; vessel and lumen profiles; and a DICOM-conformant or PDF report for healthcare-professional review.
What is its most important limitation?Key limitation: The service analyzes previously acquired CCTA rather than acquiring images. Caristo describes trained operators reviewing outputs before delivery, but plaque measurements and stenosis estimates remain adjunctive and require clinician review. FDA validation is regulatory and not independent clinical-outcome evidence.
Clinical takeaway
Clinical role: CaRi-Plaque is a web-based post-processing tool for trained operators and healthcare professionals that analyzes previously acquired CCTA DICOM data for coronary plaque characteristics, plaque burden, luminal stenosis, and related vessel measurements.
Evidence takeaway
Evidence from the reviewed source record: K242240 FDA evidence is a four-site regulatory validation of CaRi-Plaque measurements from CCTA; no independent paper or trial was promoted in this timeboxed review.
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
CaRi-Plaque is a web-based post-processing tool for trained operators and healthcare professionals that analyzes previously acquired CCTA DICOM data for coronary plaque characteristics, plaque burden, luminal stenosis, and related vessel measurements.
Trained internal operators and healthcare professionals reviewing adult CCTA-derived plaque analysis; the report supports but does not replace clinical judgment.
Post-processing and report generation for coronary plaque composition, burden, remodeling, and luminal stenosis assessment from an existing CCTA examination.
Maximum stenosis; total, calcified, non-calcified, and low-density non-calcified plaque volumes; plaque burden; remodeling index; vessel and lumen profiles; and a DICOM-conformant or PDF report for healthcare-professional review.
The service analyzes previously acquired CCTA rather than acquiring images. Caristo describes trained operators reviewing outputs before delivery, but plaque measurements and stenosis estimates remain adjunctive and require clinician review. FDA validation is regulatory and not independent clinical-outcome evidence.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
CCTA data can be transferred through secure PACS or local hard drive and the report can be delivered in DICOM-conformant or PDF form; local PACS/RIS routing, identifiers, report ingestion, and turnaround should be acceptance-tested.
The exact FDA packet and Caristo product page describe web-based processing in off-site or cloud data-center infrastructure with secure transfer and de-identification before processing; current hosting region, retention, availability, and service-level terms remain unestablished.
Caristo states that it de-identifies data before cloud processing and that trained internal operators review results; this public family statement is not a scoped security attestation for the K242240 deployment.
Public source
Product family
Checked 2026-09-07
Confirm exact deployed controls, encryption, identity and access management, audit, retention, incident response, hosting region, and data-processing terms.
Trained internal operators review processing and healthcare professionals review the returned report; local clinical users need onboarding for CCTA eligibility, report interpretation, discrepancy escalation, and integration failure handling.
Caristo describes transfer of CCTA data through secure PACS or local hard drive, de-identification before cloud processing, internal operator review, and delivery of DICOM-conformant or PDF reports; validate local transfer, identifiers, turnaround, and report ingestion.
product family · checked 2026-09-07
Current CaRi-Plaque family page; confirm exact K242240 release, contract data boundary, and operating terms.
The reviewed exact FDA packet describes off-site regional data-center processing, while the current family page describes de-identification before cloud processing; confirm hosting region, retention, availability, and data-processing terms for deployment.
The official CaRi-Plaque page lists maximum stenosis, total/calcified/non-calcified/low-density plaque volumes, plaque burden, and remodeling outputs, allowing buyer acceptance criteria to be tied to the returned report.
product family · checked 2026-09-07
Current family report description; exact K242240 output formatting and workflow configuration require confirmation.
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
K242240 FDA evidence is a four-site regulatory validation of CaRi-Plaque measurements from CCTA; no independent paper or trial was promoted in this timeboxed review.
DesignRetrospective multi-site regulatory validation comparing CaRi-Plaque plaque and stenosis measurements with reference measurements.
Population117 subjects, 85 men and 32 women aged 27-85, from four sites including two U.S. and two outside the U.S.; CT scanners included Toshiba, GE, Philips, and Siemens.
Scopeexact submission
Tested versionCaRi-Plaque configuration described in K242240
Samplen=117
Sites4
IndependenceSponsor or vendor study
K242240
Manufacturer-submitted FDA evidence; it is not an independent clinical-outcome study.
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 or contract unit for the exact K242240 configuration was established in the reviewed official sources.
Reimbursement and coding
CMS LCD L39913 v7 and Article A59813 v6 provide conditional service-level policy context for AI-QCT/AI-CPA after completed and interpreted CCTA in WPS Medicare J5/J8 for selected symptomatic chest-pain patients; exact product/version eligibility and individual claim eligibility are not established.
Public source
Product family
Checked 2026-09-07
Service-level policy context; exact product/version and individual claim eligibility are not established. This is not a product code assignment, universal Medicare coverage determination, fee, or price.
Medicare / WPS · United States - WPS J5/J8 jurisdictions · Effective 2026-01-01
CMS policy context applies to an eligible CCTA plaque-analysis service in a limited WPS policy scope; it does not assign coverage to K242240 or establish individual claim eligibility.
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 K242240. This does not establish absence of family, later-version, or adverse-event information.
Verify pricing and total cost: No public list price or contract unit for the exact K242240 configuration was established in the reviewed official sources.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-07Last searched
24Fields reviewed
12Source classes checked
0Screened PubMed leads
0Screened 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, payer policy, fda device recall, literature index, trial registry, stored candidate metadata, 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 history10 sources - 3 history items
cvi42 Coronary Plaque supports qualified professionals with viewing, post-processing, and qualitative and quantitative evaluation of adult cardiac CT DICOM images to assess the...
Careverse CoronaryDoc is a web-based tool for trained medical professionals to view and analyze CCTA CT data for coronary plaques and stenosis, with coronary measurements,...