TeraRecon Cardiovascular.Calcification.CT

by TeraRecon  · Based in United States → — Clinical AI and imaging workflows automate insights and aid care
Cardiology Cardiothoracic Surgery Radiology
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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/MRI Analysis
TeraRecon Cardiovascular.Calcification.CT is an AI-powered software that analyzes CT images to automatically detect and measure calcifications in the cardiovascular system. It provides automatic 3D segmentation of calcified plaques within the coronary arteries and outputs a mask for calcium scoring systems. The software is designed to analyze CT heart without contrast DICOM images. TeraRecon's broader advanced visualization solutions, including Intuition, also offer comprehensive cardiac CT and MR workflows, including cardiac structure segmentation, functional analysis, automated centerline creation, vessel segmentation, and calcium scoring with multiple database options. It also supports pre-operative evaluation of coronary arteries for plaque and stenosis, and embedded geometry for virtual stent evaluation.
Coronary Artery Assessment
The tool provides automatic 3D segmentation of calcified plaques within the coronary arteries. It supports calcium scoring measurements, including Agatston score, volume, and mean mass (mg). The software also offers vascular evaluation tools for plaque, soft plaque, stenosis, curvature, and tortuosity. It can merge polar maps from LV and RV ejection fraction with coronary marks for territory mapping of affected AHA 17 segments for heart function evaluation.
Heart Failure Risk Prediction
While TeraRecon Cardiovascular.Calcification.CT directly focuses on calcification, studies suggest that CT calcium score scans, by quantifying coronary artery calcification (CAC) and extracting radiomic features of epicardial adipose tissue (EAT), can be opportunistically repurposed to predict heart failure risk.
AHA/ACC Guideline Alignment
The calcium scoring capabilities align with major global coronary artery calcium guidelines, which use CAC scores in atherosclerotic cardiovascular disease (ASCVD) risk assessment to facilitate physician-patient decisions regarding treatment options, such as statin therapy.
Real-Time Alert Capability
TeraRecon's Eureka Clinical AI platform, which hosts the Cardio Suite (including Coreline Soft's AVIEW CAC AI algorithm for automated calcium scoring), supports robust notification and communication tools, providing access to time-sensitive decision support.
Physician Tip

TeraRecon Cardiovascular.Calcification.CT is a powerful tool for efficiently assessing cardiovascular health and risks through automated detection and measurement of calcifications in CT images. It's crucial to remember that the results are intended to be used in conjunction with other patient information by trained professionals for making patient management decisions. The software is particularly useful for quantifying coronary artery calcification (CAC) using the Agatston score, volume, and mean mass, which are key indicators for atherosclerotic cardiovascular disease (ASCVD) risk. The ability to analyze coronary vessels with 'zero-click centerline creation and extraction' can significantly streamline workflow. Consider integrating this tool for comprehensive cardiac CT analysis, especially for pre-operative planning and follow-up studies.

TeraRecon Cardiovascular.Calcification.CT is a software as a medical device (SaMD) deployed as a containerized application. It inputs CT heart without contrast DICOM images and outputs DICOM result files, which can be viewed using DICOM-compliant systems. The broader TeraRecon Intuition platform, which includes these capabilities, is designed for interoperability with DICOM and HL7 integration. TeraRecon solutions are independent of any specific manufacturer's imaging equipment or PACS, allowing for a unified workflow. The Eureka Clinical AI platform also allows for user-selected integration with third-party 3D segmentation models for clinical research.

Details

Category Cardiology AI
Pricing Unknown
DeploymentCloud-enabled imaging platform.
TrainingUnknown
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Yes AI-estimated
Integrations
EHR Not specified
Specialties Cardiology, Cardiothoracic Surgery, Radiology

Support & Reliability

Training ProvidedUnknown

What the Web Says

TeraRecon Cardiovascular.Calcification.CT is a software as a medical device (SaMD) designed for the automatic 3D segmentation of calcified plaques within coronary arteries from CT heart images. It provides a mask for calcium scoring systems and is intended to be used by trained professionals in conjunction with other patient information for clinical decision-making. The software aims to streamline workflows, enhance diagnostic confidence, and optimize reimbursement potential for healthcare providers.

Overall: Positive

Strengths

  • Accurate segmentation of calcified plaques in coronary arteries.
  • Improved performance and efficiency in cardiac CT studies with less operator interaction.
  • Ease of use and intuitive interface.
  • Web-based solution allows access from anywhere, facilitating remote review and collaboration.
  • Robust and well-trained support staff.
  • Versatile for various medical specialties beyond vascular surgery, such as colorectal and thoracic.

Limitations

  • The device does not alter original input data and does not provide a diagnosis.
  • Does not output Agatston scores directly.
  • Some components of the solution may be awaiting regulatory clearance.
  • Reddit discussions indicate that some users may still prefer traditional axial measurements for basic cases over 3D reconstruction.
  • Limited information available from independent tech reviewers, G2, and Capterra specifically for the "Cardiovascular.Calcification.CT" product.

Based on reviews from: terarecon.com, innolitics.com, youtube.com, slashdot.org, fda.gov, itnonline.com, dicardiology.com, softwareadvice.com, reddit.com

Last updated: 2026-10-27

Ratings & Reviews

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Press & Coverage

Innolitics
TeraRecon Cardiovascular.Calcification.CT (K250288, Oct 2025): Described as a "containerized application (e.g., Docker)."
TeraRecon Cardiovascular.Calcification.CT, cleared in October 2025, is highlighted as a containerized application, demonstrating the medical device industry's adoption of modern software deployment methods like Docker.
2026-04
TeraRecon
TeraRecon Cardiovascular.Calcification.CT Intended Use
TeraRecon Cardiovascular.Calcification.CT is a software as a medical device (SaMD) designed for automatic 3D segmentation of calcified plaques in coronary arteries from CT heart images, providing a mask for calcium scoring systems.
unknown
FDA
FDA 510(k) Premarket Notification for TeraRecon Cardiovascular.Calcification.CT
The FDA granted 510(k) clearance to TeraRecon Cardiovascular.Calcification.CT on October 23, 2025, classifying it as an automated radiological image processing software.
2025-10
Innolitics
Comprehensive analysis of 2025 cardiology AI/ML clearances, market trends, capital events, and regulatory insights
TeraRecon Cardiovascular.Calcification.CT was among the 92 AI/ML-related FDA clearances in 2025, specifically noted in the category of CAC-related devices.
2026-01
Blue Cross Blue Shield of Kansas
Coronary Artery Calcium Scoring - Medical Policy
TeraRecon Cardiovascular.Calcification.CT (K250288) is listed as one of several FDA-cleared AI-enabled post-processing software products for CAC analysis as Class II devices through the 510(k) pathway.
2026-09
AstraRad
SCCT releases new guideline for training cardiology and radiology trainees in CCT
The article mentions TeraRecon Cardiovascular.Calcification.CT (K250288) in the context of FDA-cleared segmentation tools for cardiac CT teleradiology, emphasizing that these tools produce masks or measurements that require interpretation by a trained professional.
2026-09
FDA
510(k) Substantially Equivalent Decisions
The FDA determined that TeraRecon Cardiovascular.Calcification.CT (K250288) is substantially equivalent to predicate devices, indicating its safety and effectiveness.
2026-10

Videos

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

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Frequently Asked Questions

TeraRecon Cardiovascular.Calcification.CT is an AI-powered software as a medical device (SaMD) that automatically segments calcified plaques within the coronary arteries from CT heart scans without contrast. It generates a mask for calcium scoring systems to use for calculations, assisting trained professionals in assessing cardiovascular health and risk.
This device is intended for adult patients 30 years and older, excluding those with pre-existing cardiac devices, electrodes, established ischemic diseases (IMA, bypass grafts, stents, PTCA), or thoracic metallic devices. It is also recommended for use only with CT scans acquired on General Electric (GE) or Siemens Healthcare equipment. The device does not alter original input data or provide a diagnosis; its results are to be used in conjunction with other patient information and professional judgment.
TeraRecon Cardiovascular.Calcification.CT is a software as a medical device (SaMD) and has received FDA 510(k) clearance. It processes DICOM images and outputs DICOM result files that can be viewed by DICOM-compliant systems, ensuring compatibility and adherence to medical imaging standards. TeraRecon also provides electronic user manuals and emphasizes data security and privacy.
Several other software solutions offer plaque analysis and characterization, including Siemens Healthcare's Circulation and Vital Images' Vitrea. Additionally, other AI algorithms like Coreline Soft's AVIEW CAC, available on TeraRecon's Eureka Clinical AI platform, also provide automated calcium scoring, even on low-dose CTs without ECG-gating.
TeraRecon offers its AI solutions, including CT Cardiac capabilities which encompass calcium scoring, through a simple and predictable annual subscription-based pricing model. This approach aims to provide a lower total cost of ownership by consolidating systems and avoiding capital expenses.
Yes, TeraRecon Cardiovascular.Calcification.CT is designed to integrate into existing workflows. It is deployed as a containerized application and outputs DICOM result files, which can be viewed and utilized by other DICOM-compliant systems, including PACS. TeraRecon's solutions are independent of specific imaging equipment or PACS, allowing for a unified clinical workflow.

Compare TeraRecon Cardiovascular.Calcification.CT

VS
TeraRecon Cardiovascular.Calcification.CT vs IM007
Cardiology AI Adjacent · 60/100
Tool A, TeraRecon Cardiovascular.Calcification.CT, specializes in AI-powered analysis of CT images for coronary artery calcification and vessel assessment, primarily aiding in diagnostic imaging. In contrast, Tool B, IM007…
VS
ASSURE Wearable ECG vs TeraRecon Cardiovascular.Calcification.CT
Cardiology AI Adjacent · 60/100
These tools are adjacent rather than direct competitors, as they address different aspects of cardiac patient care. Tool A focuses on continuous, real-time heart rate monitoring and data…
VS
TeraRecon Cardiovascular.Calcification.CT vs Rhythm360
Cardiology AI Adjacent · 60/100
Tool A is designed for detailed AI-powered analysis of CT images to detect and quantify coronary artery calcifications, aiding in risk stratification and diagnosis. Tool B, conversely, is…
VS
Acumen Hypotension Prediction Index (HPI) Feature Software vs TeraRecon Cardiovascular.Calcification.CT
Cardiology AI Adjacent · 65/100
Tool A focuses on real-time predictive monitoring of hypotensive events using hemodynamic data to aid in proactive management within acute care settings. In contrast, Tool B is an…

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