Radiology AI Directory

FDA-cleared profile

DEEPVESSEL Plaque

Keya Medical Technology Co., Ltd.

Authorized purpose: Coronary plaque and stenosis quantification from CCTA

Cardiac imagingQuantification and segmentation
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: Coronary plaque and stenosis quantification from CCTA

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Coronary plaque and stenosis quantification from CCTA

Evidence takeaway

Evidence from the reviewed source record: Standalone study used 147 CCTA cases from three US sites with three-expert consensus reference; it did not use IVUS or histology as reference.

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
Coronary plaque and stenosis quantification from CCTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Intended users
Qualified clinicians and trained analysts/operators
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Care setting and population
Adults age 22 and older with known or suspected coronary artery disease
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Workflow role
Measurement, quantification and diagnostic support
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Required input
CCTA DICOM acquired on CT systems with at least 64 detector rows
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Output and human action
Vessel/lumen/wall segmentations; total, calcified, non-calcified and low-density plaque volumes/burden; stenosis measures; CAD-RADS category; Cardisight Overview and Plaque Analysis reports
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Limitations
Qualified clinician review and analyst correction are required. Interpolated views may appear healthy where pathology is near or below scanning resolution.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

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
K260497
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Anatomy
Heart/Cardiovascular
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-06-04
  • 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
Web-based workflow with secure PACS data transfer described in FDA review
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

This data-flow description is not a current security certification.

Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Hosting region, retention, supported PACS interfaces and purchased configuration were not established.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

No dated, scoped security attestation reviewed.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Analyst credentialing, correction workflow and cardiologist review protocol require confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Reanalysis turnaround and analyst correction audit processes need local confirmation.

Current product-family reporting

Vendor describes analyst review and two plaque-analysis reports.

product family · checked 2026-09-05

Separate FFR features are not attributed to DEEPVESSEL Plaque.

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
Standalone study used 147 CCTA cases from three US sites with three-expert consensus reference; it did not use IVUS or histology as reference.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Reported sensitivity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-05

No clinically interpretable sensitivity estimate was established in the reviewed summary.

Reported specificity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-05

No clinically interpretable specificity estimate was established in the reviewed summary.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K260497 CCTA plaque/stenosis study

  • DesignStandalone expert-reference comparison
  • PopulationCCTA cases from three US sites
  • Scopeexact submission
  • Tested versionDEEPVESSEL Plaque in K260497
  • Samplen=147
  • Sites3
  • IndependenceIndependence not established

K260497

Reference is three-expert consensus, not IVUS or histology.

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 2026-09-05

No public exact-version rate or procurement award reviewed.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-05

No applicable payer policy reviewed.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

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
2026-09-06Last searched
19Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

Stored PubMed and clinical-trial candidate arrays are empty and were screened. No study was fabricated from vendor validation material. 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, acr ai central product, fda decision summary, vendor product page, literature index, trial registry, recall database, 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. K260497 FDA decision source

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, purpose, modality, anatomy

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. DEEPVESSEL Plaque model card (K260497)

    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. DEEPVESSEL Plaque: K260497 decision and 510(k) summary

    U.S. Food and Drug Administration - Accessed 2026-09-05

    Scope: identity, clinical, evidence, implementation

  8. DEEPVESSEL Plaque

    Keya Medical - Accessed 2026-09-05

    Scope: implementation

Research history

  1. K260497 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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