DEEPVESSEL Plaque
by Keya Medical Technology Co., Ltd.
· Based in China →
— FDA-cleared AI-powered CCTA analysis to quantify plaque burden, characterize plaque, and assess coronary stenosis.
Overview
DEEPVESSEL Plaque by Keya Medical Technology Co., Ltd. is an AI-powered medical tool designed for the analysis of coronary computed tomography angiography (CCTA) studies.
- What it does: The tool characterizes and quantifies coronary atherosclerotic plaque and stenosis from previously acquired CCTA images. It provides quantitative measurements including total plaque volume, calcified and non-calcified plaque volume, low-density plaque volume, plaque burden, and stenosis severity, along with CAD-RADS stenosis categorization.
- Who it is for: DEEPVESSEL Plaque is intended for qualified clinicians to assess the presence and extent of coronary artery disease (CAD) in adults with suspected or known CAD. This includes specialties such as cardiology and radiology, and it can be utilized in care settings where CCTA studies are performed and interpreted.
- How it fits a clinical or practice workflow: The workflow involves secure transfer of previously acquired CCTA DICOM data. Deep-learning-based segmentation is then performed and reviewed by trained analysts. Finally, quantitative and visual clinical reports are delivered for review by the clinician.
- Notable capabilities: DEEPVESSEL Plaque offers detailed vessel- and patient-level plaque volumes, burden, composition, and stenosis assessment through visual clinical reports. It is an FDA-cleared solution for coronary CTA analysis.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered coronary plaque analysis
- Quantifies plaque burden
- Characterizes plaque composition (calcified, non-calcified, low-density)
- Assesses coronary stenosis
- Provides quantitative plaque measurements
- Generates visual clinical reports
- Segments coronary arteries, vessel walls, and lumen structures
- Supports clinical decision-making for coronary artery disease (CAD)
- Compatible with previously acquired CCTA studies
- Integration with DEEPVESSEL FFR for comprehensive cardiac analysis
Use Cases
- Assessing the presence and extent of coronary atherosclerosis
- Evaluating coronary artery disease (CAD) in adults with suspected or known CAD
- Supporting clinical decision-making for patient management strategies
- Complementing expert CCTA interpretation with standardized, scalable AI-assisted plaque assessment
What Physicians Need to Know
Cardiac CT/MRI Analysis
DEEPVESSEL Plaque is an FDA-cleared AI-powered software that analyzes previously acquired Coronary Computed Tomography Angiography (CCTA) data. It provides quantitative plaque measurements, characterizes plaque, and assesses stenosis.
Coronary Artery Assessment
The tool helps clinicians assess the presence and extent of coronary atherosclerosis by providing quantitative plaque measurements, stenosis categorization, and visual clinical reports. It quantifies total plaque volume, non-calcified plaque volume, calcified plaque volume, low-density plaque volume, and plaque burden.
AHA/ACC Guideline Alignment
While DEEPVESSEL Plaque itself is not explicitly stated to be aligned with AHA/ACC guidelines in the provided information, the broader context of quantitative coronary plaque analysis from CCTA is supported by recent ACC/AHA scientific statements. These statements highlight the prognostic value of quantifying coronary plaque and reinforce the role of CCTA in CAD patient management.
Physician Tip
DEEPVESSEL Plaque offers a comprehensive anatomical assessment of coronary artery disease. Combining its quantitative plaque analysis and stenosis evaluation with DEEPVESSEL FFR (a separate, complementary tool for functional assessment) can provide a more complete picture from a single CCTA examination, aiding in more precise risk stratification and personalized treatment planning. The detailed reports, including plaque volumes, burden, composition, and stenosis assessment, can be valuable for monitoring disease progression and guiding therapeutic interventions.
DEEPVESSEL Plaque processes previously acquired CCTA DICOM data through a secure remote workflow. It is designed to complement DEEPVESSEL FFR, with both being separately FDA-cleared products that can be used together for a more comprehensive CCTA assessment.
Details
| Category | Cardiology AI, Radiology & Imaging AI |
| Pricing | Unknown — unknown |
| Deployment | Cloud-based |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Unknown AI-estimated DEEPVESSEL Plaque received FDA 510(k) clearance (K260497) on June 4, 2026, as automated radiological image-processing software under 21 CFR 892.2050 (product code QIH). It cleared via the Traditional 510(k) pathway with a finding of substantial equivalence, positioning it as a measurement and visualization aid on coronary CT. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Cardiothoracic Surgery, Radiology |
What the Web Says
DEEPVESSEL Plaque is an FDA-cleared, AI-powered software that analyzes coronary CT angiography (CCTA) scans to quantify atherosclerotic plaque and assess stenosis. It provides detailed measurements of plaque volume and categorization of stenosis, aiming to offer a more comprehensive understanding of coronary artery disease beyond just luminal narrowing. The software is designed to assist qualified clinicians in reviewing and interpreting CCTA data, with results delivered in quantitative measurements and visual reports.
Overall: PositiveStrengths
- FDA-cleared and AI-assisted for analyzing coronary plaque and stenosis from CCTA.
- Provides quantitative measurements including total plaque volume, calcified and non-calcified plaque volume, and plaque burden.
- Offers stenosis categorization (CAD-RADSu00ae) and visual clinical reports.
- Demonstrated strong agreement with Level III expert consensus in clinical validation studies for plaque assessment and CAD-RADS categorization.
- Aids in assessing the presence and extent of coronary atherosclerosis, offering more than just luminal narrowing.
- Utilizes deep-learning technology for robust vessel and lumen segmentation.
Limitations
- The software is for image processing and analysis, providing quantitative measurements, but does not render an autonomous diagnosis.
- Clinical validation studies, while showing strong agreement with expert consensus, did not use independent modalities like IVUS or histology as a reference standard.
- No specific reviews from G2, Capterra, or tech reviewers were found.
- Reddit discussions about plaque reduction primarily focus on supplements like Nattokinase and Serrapeptase, not medical devices like DEEPVESSEL Plaque.
Based on reviews from: KeyaMedical, DeviceClaims, AuntMinnie, PubMed, Reddit
Last updated: 2026-09-24
Ratings & Reviews
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Press & Coverage
AuntMinnie
Keya Medical wins FDA clearance for CCTA software
Keya Medical received 510(k) clearance from the FDA for DeepVessel Plaque, an AI-powered tool for coronary CT angiography (CCTA) that quantifies coronary plaque and assesses stenosis. The cloud-based software uses deep-learning technology to segment coronary arteries, vessel walls, and lumen structures, providing quantitative measurements including total plaque volume, calcified and non-calcified plaque volume, low-density plaque volume, plaque burden, stenosis severity, and CAD-RADS stenosis categorization.
2026-06
DeviceClaims
DEEPVESSEL Plaque (K260497): The FDA Clearance
Keya Medical Technology Co., Ltd. received FDA 510(k) clearance (K260497) on June 4, 2026, for DEEPVESSEL Plaque, an AI coronary-plaque quantification tool. This software is classified as automated radiological image-processing software, operating on already-acquired images to produce processed or quantified output.
2026-06
Innolitics
Q2 2026 AI/ML FDA Clearances and De Novos
DEEPVESSEL Plaque by Keya Medical was among the 86 AI/ML devices authorized by the FDA in Q2 2026, receiving 510(k) clearance on June 4, 2026. This AI tool processes CCTA DICOM images to generate coronary plaque and stenosis quantification reports, assisting clinicians in assessing coronary anatomy.
2026-07
Keya Medical
Keya Medical Secures FDA Clearance for AI-Powered Coronary ...
Keya Medical announced FDA clearance for its DeepVessel Plaque AI Quantitative Analysis Technology, which aims to break down barriers in coronary plaque assessment. This technology, combined with its FFR-CT, allows for comprehensive anatomical and functional assessments from a single CCTA scan.
2026-07
Keya Medical
COMPOSE-CT Validates DEEPVESSEL Plaque Against Expert Consensus
The multicenter COMPOSE-CT study, presented at SCCT 2026, demonstrated strong agreement between DEEPVESSEL Plaque and Level III expert consensus for quantitative coronary plaque assessment and CAD-RADS stenosis categorization. The study included 147 analyzable CCTA cases and showed high correlation coefficients for various plaque volumes.
2026-08
Keya Medical
Comprehensive CCTA Assessment with DEEPVESSEL FFR and Plaque Analysis
Keya Medical highlights the comprehensive assessment capabilities when combining DEEPVESSEL FFR and DEEPVESSEL Plaque for CCTA analysis. Both are FDA-cleared products designed to provide anatomical and functional assessments of coronary artery disease.
2026-08
Keya Medical
Keya Medical to Participate in NASCI 2026
Keya Medical announced its participation in NASCI 2026, where it will showcase its DEEPVESSEL FFR and DEEPVESSEL Plaque products. These tools offer quantitative plaque assessment and functional assessment of coronary artery disease from CCTA.
2026-09
Keya Medical
DEEPVESSEL Plaque | FDA-Cleared AI Coronary Plaque Analysis
DEEPVESSEL Plaque is an FDA-cleared AI-powered coronary CTA analysis solution that characterizes and quantifies coronary atherosclerotic plaque and stenosis. It provides quantitative plaque measurements and visual reports to help clinicians evaluate the presence and extent of coronary artery disease.
2026-09
Videos
Product demos, reviews, and walkthroughs for DEEPVESSEL Plaque.
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Frequently Asked Questions
DEEPVESSEL Plaque is an FDA-cleared, AI-powered software that analyzes coronary CT angiography (CCTA) images to characterize and quantify coronary atherosclerotic plaque and stenosis. It provides quantitative plaque measurements and visual reports, helping clinicians assess the presence and extent of coronary artery disease (CAD) and support clinical decision-making.
DEEPVESSEL Plaque provides detailed quantitative measurements including total plaque volume, calcified and non-calcified plaque volume, low-density plaque volume, plaque burden, and stenosis severity. It also offers CAD-RADS stenosis categorization and visual clinical reports.
Yes, DEEPVESSEL Plaque is FDA-cleared. It received 510(k) clearance (K260497) on June 4, 2026, as automated radiological image-processing software under 21 CFR 892.2050 (product code QIH).
DEEPVESSEL Plaque is designed to analyze previously acquired CCTA studies, integrating into existing imaging workflows by providing quantitative data and visual reports for clinical review. However, it's important to note that the software processes already-acquired images and provides quantified output, rather than controlling image acquisition or rendering an autonomous diagnosis; the diagnostic responsibility remains with the clinician. High-quality CCTA images are required for accurate analysis, and plaque brightness can vary based on technical factors.
While DEEPVESSEL Plaque offers AI-powered quantitative plaque analysis, traditional methods involve manual evaluation of CCTA images, which can be time-consuming and less precise for quantifying plaque volumes. Other AI-powered solutions for cardiac CT analysis are emerging, focusing on similar goals of enhancing plaque detection and risk assessment.
Specific pricing for DEEPVESSEL Plaque is not publicly detailed, but Keya Medical, the developer, mentions 'patient- and payer-centric pricing' for its DEEPVESSEL FFR product, which is a complementary tool. For non-invasive FFR estimates derived from CCTA software analysis, a new Category I CPT code (75580) was implemented starting January 1, 2024, which may impact reimbursement for such AI-assisted analyses.
DEEPVESSEL Plaque and DEEPVESSEL FFR are complementary, separately FDA-cleared products from Keya Medical. DEEPVESSEL Plaque focuses on anatomical assessment by quantifying plaque and stenosis from CCTA. DEEPVESSEL FFR, on the other hand, is deep-learning-based software that calculates CT-derived fractional flow reserve (FFR) values from CCTA data to evaluate the functional significance of coronary artery disease.
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| Last Verified: 2026-09-23 | First Added: 2026-09-23