TeraRecon Cardiovascular.Calcification.CT

by Terarecon  · Based in United States →AI Visualizations for Automated Insights & Enhanced Patient Care.
Cardiology Cardiothoracic Surgery Radiology

Subscription-based
Regulatory Status Disclosed

Overview

TeraRecon, a ConcertAI company, develops and delivers enterprise medical image management and visualization solutions for healthcare enterprises worldwide. The company’s mission is to continuously innovate ahead of market demand to provide solutions that impact clinical care across health systems. TeraRecon’s systems utilize advanced visualization and artificial intelligence to advance the accessibility, performance, clinical functionality, and workflow integration of medical images throughout the healthcare ecosystem, enabling physicians to provide solutions that influence clinical care across health organizations. Their offerings include visualization 3D post-processing tools, as well as a spectrum of enterprise medical image viewing, diagnostic interpretation, image sharing, interoperability, and collaboration solutions.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automatic 3D segmentation of calcified plaques in coronary arteries
  • Outputs mask for calcium scoring systems
  • Supports Agatston score, volume, mean mass (mg) measurements
  • Part of CT Cardiac package with zero-click centerline creation
  • Vessel segmentation and analysis (plaque, stenosis, curvature, tortuosity)
  • Cardiac structure segmentation and functional analysis
  • Atrium & pulmonary vein analysis for EP planning
  • Pre-operative evaluation of coronary arteries
  • Embedded geometry for pre-operative virtual stent evaluation
  • DICOM result file output

Use Cases

  • Assessing cardiovascular health and risks
  • Assisting physicians in diagnosis
  • Supporting patient management decisions
  • Pre-operative evaluation of coronary arteries
  • Cardiac analysis and quantification
  • Expediting disease diagnosis and care coordination

What Physicians Need to Know

Cardiac CT Analysis
Provides automatic 3D segmentation of calcified plaques within coronary arteries from CT heart images. It supports cardiac structure segmentation and functional analysis, including 2D, 3D, and 4D visualization.
Coronary Artery Assessment
Enables comprehensive coronary artery assessment through automated centerline creation, vessel segmentation, and measurement of Agatston score, volume, and mean mass (mg) of calcium. It also supports pre-operative evaluation for plaque and stenosis.
Heart Disease Risk Stratification
Generates Coronary Artery Calcification (CAC) scores, which are strong predictors of atherosclerotic cardiovascular disease (ASCVD) events, aiding in risk stratification and informing treatment decisions.
AHA/ACC Guideline Alignment
Facilitates CAC scoring, which is a Class IIa recommendation in 2019 ACC/AHA guidelines for primary prevention of cardiovascular disease to guide shared decision-making for statin therapy in intermediate-risk individuals. It also supports territory mapping of affected AHA 17 segments.
Automated Workflows
Offers simplified, semi-automated, and zero-click workflows for complex cardiac analysis and quantification, reducing image interpretation times and improving efficiency.
Physician Tip

TeraRecon Cardiovascular.Calcification.CT is invaluable for efficiently quantifying coronary artery calcification from CT scans, providing critical data for ASCVD risk stratification and guiding preventive interventions. Leverage its automated scoring and visualization capabilities to streamline workflow and enhance diagnostic confidence in identifying patients who may benefit from statin therapy or further risk factor modification, aligning with current ACC/AHA guidelines. The ability to work with non-ECG-gated low-dose CTs expands its applicability.

This software as a medical device (SaMD) is deployed as a containerized application, accepting CT heart without contrast DICOM images as input. It outputs DICOM result files that can be viewed and utilized by other DICOM-compliant systems, ensuring seamless integration with existing PACS and RIS infrastructure.

Details

Category Cardiology AI
Pricing Subscription-based Single annual fee; eliminates annual service renewals; operational budget flexibility.
DeploymentContainerized application (SaMD), also available as SaaS within Eureka Clinical AI platform.
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

Cleared by the FDA on October 23, 2025, under K250288. TeraRecon Cardiovascular.Calcification.CT is intended for automatic 3D segmentation of calcified plaques within coronary arteries, outputting a mask for calcium scoring systems.

Integrations
EHR Not specified
Specialties Cardiology, Cardiothoracic Surgery, Radiology

What the Web Says

TeraRecon Cardiovascular.Calcification.CT is a software as a medical device (SaMD) designed for automatic 3D segmentation of calcified plaques in coronary arteries, providing a mask for calcium scoring systems. It aims to simplify complex cardiac analysis and quantification, enabling radiologists and cardiologists to analyze coronary vessels with features like zero-click centerline creation and extraction. The software is intended to be used by trained professionals in conjunction with other patient information for making patient management decisions.

Overall: Positive

Strengths

  • Automated 3D segmentation of calcified plaques and calcium scoring.
  • Simplified approach to complex cardiac analysis and quantification.
  • Zero-click centerline creation and extraction for coronary vessel analysis.
  • Web solution allows access from anywhere.
  • Integrates with existing PACS solutions and offers AI-driven automations.
  • Intuitive interface and strong customer support.

Limitations

  • One study indicated TeraRecon had the largest deviation from true size in measuring thoracic aortic aneurysms compared to Siemens and GE workstations, although with the smallest fluctuation.
  • Some radiologists on Reddit indicated they don't always use 3D reconstructions for diagnosis, or that their use is dependent on hospital policy or specific case complexity.
  • Coronary Artery Calcium (CAC) scans are not recommended for following a patient's risk over time or for patients with established heart disease.

Based on reviews from: TeraRecon Intuition Testimonial | Dr. Michael Poon - YouTube, Reg Resource - TeraRecon, TeraRecon DETECT, CT Cardiac Advanced Visualization Package - TeraRecon, CT Cardiac Package Tour | TeraRecon Advanced Visualization, TeraRecon Introduces Aquarius iNtuition for Cardiac Imaging, TeraRecon | AI & Advanced Visualization for Medical Imaging, 3D overload : r/Radiology - Reddit, ConcertAI Introduces TeraRecon AVu2122*, Advancing AI-Powered Medical Imaging with New Structural Heart and SaaS Capabilities, Comprehensive comparison of three different workstations for accurate planning of endovascular stent implantation in patients with thoracic aortic aneurysms - PMC, Detection of coronary artery calcification with nontriggered computed tomography of the chest - PMC, Advances in CT Techniques in Vascular Calcification - PMC - NIH, Coronary Calcium CT : r/FamilyMedicine - Reddit, Good bloodwork, but shocked by coronary calcium score ... next steps? - Reddit, TeraRecon Overview - YouTube, Resource Center - TeraRecon, TeraRecon's New Intuition Product Line Delivers AI Productivity and Industry-leading Cardiac MR Workflows, All Delivered Through a Robust Software-as-a-Service (SaaS) Platform, K250288 - 510(k) Premarket Notification - FDA, Cardiovascular CT Imaging Reviews, Testimonials - KeyaMedical, CT Scan for Coronary Artery Calcification Window - YouTube, The Best CT Scanner for Cardiac Imaging - Guide

Last updated: 2026-07-19

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Press & Coverage

Constat
TeraRecon Cardiovascular.Calcification.CT (K250288) u2014 FDA 510(k) evidence
TeraRecon Cardiovascular.Calcification.CT received FDA 510(k) clearance (K250288) on October 23, 2025, for its AI-powered software that automatically segments calcified plaques in coronary arteries from CT images. The clearance was based on a validation study and a cited predicate, with the device intended for use by trained professionals in conjunction with other patient information.
2025-10
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances
This article provides a comprehensive analysis of 2025 cardiology AI/ML clearances, highlighting TeraRecon Cardiovascular.Calcification.CT (K250288) as one of the cleared devices for coronary artery calcification analysis. The report notes a significant increase in AI/ML-related FDA clearances in 2025, with coronary CT being a major category.
2026-01
Innolitics
How to Get Your AI-Generated, Vibe-Coded Medical Device FDA-Cleared
TeraRecon Cardiovascular.Calcification.CT (K250288) is cited as an example of a cleared AI/ML Software as a Medical Device (SaMD) that is deployed as a containerized application. The article discusses the FDA's adaptability to modern software development practices, including containerization.
2026-04
X-ray Interpreter
AI-CAD identifies 89.9% of breast cancers in 24K+ screens | Rad AI Slice
This news brief mentions TeraRecon Cardiovascular.Calcification.CT (K250288) as an AI tool for detecting and quantifying CT cardiovascular calcifications to enhance cardiac disease risk assessment. It was included in a list of recently FDA-approved devices.
2025-11
Medical AI Tools for Physicians
TeraRecon Cardiovascular.Calcification.CT vs VX1 - Medical AI Tools for Physicians
This comparison highlights TeraRecon Cardiovascular.Calcification.CT as an AI tool designed for automated, precise analysis of CT images for coronary artery calcification scoring and comprehensive cardiac structural assessment, primarily for pre-procedural analysis. It aids radiologists and cardiologists in streamlining diagnostic workflows and quantifying cardiovascular risk.
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TeraRecon
TeraRecon Cardiovascular.Calcification.CT
TeraRecon Cardiovascular.Calcification.CT is an AI-powered software as a medical device (SaMD) that provides automatic 3D segmentation of calcified plaques within coronary arteries. It outputs a mask for calcium scoring systems and is intended for use by trained professionals in conjunction with other patient information.
unknown
Medical AI Tools for Physicians
TeraRecon Cardiovascular.Calcification.CT vs CardioLogs ECG Analysis Platform
This comparison details TeraRecon Cardiovascular.Calcification.CT's focus on AI for automated and precise quantification of coronary artery calcifications from CT images, supporting advanced calcium scoring and plaque analysis for cardiovascular risk stratification. It is available as a containerized application or SaaS.
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TeraRecon
User Manuals Page - TeraRecon
TeraRecon provides electronic user manuals for its products, including TeraRecon Cardiovascular.Calcification.CT, accessible online or within the medical device software. Customers can also request hard copies of the manuals.
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Videos

Product demos, reviews, and walkthroughs for TeraRecon Cardiovascular.Calcification.CT.

View all on YouTube

Frequently Asked Questions

TeraRecon Cardiovascular.Calcification.CT is a software as a medical device (SaMD) that automatically segments calcified plaques within coronary arteries from non-contrast CT heart DICOM images. It generates a mask for calcium scoring systems, providing Agatston scores, volume, and mean mass, which can be viewed on DICOM-compliant systems to aid cardiologists in analysis.
Yes, TeraRecon Cardiovascular.Calcification.CT received FDA 510(k) clearance on October 23, 2025, under the product code QIH for Automated Radiological Image Processing Software. This clearance confirms its regulatory compliance as a medical device.
This AI tool is indicated for adult patients 30 years and older but should not be used in patients with pre-existing cardiac devices, electrodes, established ischemic diseases (IMA, bypass grafts, stents, PTCA), or thoracic metallic devices. It does not provide a diagnosis and its results must be used in conjunction with other patient information and professional judgment.
While TeraRecon's platform can integrate third-party AI solutions, Coreline Soft's AVIEW CAC AI algorithm is mentioned as a partner within TeraRecon's Cardio Suite for automated CAC scoring. The broader market for cardiac CT post-processing software includes various vendors offering similar capabilities for image interpretation.
Specific pricing details are not publicly disclosed, but TeraRecon generally offers its advanced visualization solutions, including AI components, through a subscription-based purchasing model. This approach aims to provide financial flexibility with a single annual charge, eliminating separate annual service renewals.
The solution automates the time-consuming measurement of calcified plaques, offering features like zero-click centerline creation and extraction, which streamlines the analysis process. It can also provide CAC scores from low-dose and non-gated CTs, expanding its applicability and improving workflow efficiency.
Physicians retain full responsibility for patient management decisions, as the AI tool does not provide a diagnosis and its results are intended to assist, not replace, clinical judgment. Users must be trained in the software's functions, capabilities, and limitations, and integrate the AI-derived findings with all other relevant patient information.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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