HealthCCS

by Zebra Medical Vision  · Based in Israel → — AI-powered medical imaging solutions for enhanced diagnostics and patient care.
Emergency Medicine Orthopedics Radiology

Subscription-based; licensing agreements; historical offering of $1 per scan for its ai1 suite.
Regulatory Status Disclosed

Overview

Zebra Medical Vision, now part of Nanox.AI, is a leading provider of AI-powered medical imaging solutions designed to assist radiologists and healthcare providers in disease detection and analysis. Leveraging deep learning algorithms, the platform analyzes various medical images, including X-rays, CT scans, and MRIs, to identify abnormalities and potential concerns. The company’s mission is to empower clinicians with advanced tools to improve diagnostic accuracy, reduce diagnostic errors, and achieve better patient outcomes by streamlining workflows and enabling earlier detection of a wide range of conditions.

The solutions are built to integrate seamlessly into existing healthcare infrastructure, such as PACS and EHR systems, providing AI-driven insights directly into clinical practice. Zebra Medical Vision focuses on population health management and preventative care, offering algorithms that can identify patients at risk for chronic conditions like cardiovascular disease and osteoporosis, as well as acute conditions such as brain bleeds and pneumothorax.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered medical image analysis software
  • Disease detection (e.g., cancer, cardiovascular, liver, bone, brain bleeds, pneumothorax, pleural effusion)
  • Predictive analytics for patient outcomes and preventive care
  • Triage solutions for urgent findings (e.g., brain bleeds, pneumothorax)
  • 3D modeling from X-rays for orthopedic surgery planning
  • Integration with PACS and EHR systems
  • Automated detection of critical findings with priority flagging
  • Multi-modality AI analysis (X-ray, CT, MRI, Mammography)
  • Population health management capabilities
  • Reduced diagnostic interpretation time

Use Cases

  • Early detection and diagnosis of various diseases (e.g., cancer, cardiovascular conditions, osteoporosis)
  • Assisting radiologists in interpreting medical images and highlighting potential concerns
  • Prioritizing urgent cases for faster diagnosis and intervention (triage)
  • Population health screening to identify at-risk patients for preventative care
  • Orthopedic surgery planning using 3D bone models from X-rays
  • Reducing diagnostic errors and improving consistency across providers

What Physicians Need to Know

DICOM Support & Standards
HealthCCSng supports native DICOM integration, accepting DICOM images from adult patients as valid input for analysis.
PACS Integration Method
The solution offers native PACS and EHR system connectivity, facilitating seamless workflow integration. Analysis results are provided to Zebra's Imaging Analytics Platform (IMA) or directly to the PACS/workstation for prioritization.
Reading Room Workflow Impact
HealthCCSng operates in parallel with the standard of care workflow, providing automated detection and categorization of coronary calcium. It generates a risk category output and preview axial images with annotated calcified areas for radiologist review, aiming to augment productivity and reduce diagnostic interpretation time by flagging suspicious studies for prioritization.
AI Model Architecture (deep learning approach)
The tool leverages advanced deep learning algorithms and machine learning for the automated detection and estimation of coronary artery calcium. Specifically, it employs a CNN-based probability threshold to identify calcification.
FDA Clearance Pathway (510k/De Novo)
HealthCCSng received U.S. FDA 510(k) clearance. Its predicate device was the earlier HealthCCS (K172983).
Supported Modalities (CT/MRI/X-ray/US)
The HealthCCSng solution is specifically designed to analyze non-cardiac-gated CT scans that include the heart, opportunistically quantifying coronary artery calcium.
Sensitivity & Specificity Data
For HealthCCSng, the overall agreement with ground truth for coronary calcium detection category was found to be equal to or superior to 85% compared to its predicate device. An earlier HealthCCS device demonstrated an overall agreement of 0.89 (95% CI: [0.85, 0.92]) for 4-level risk categorization. The addition of Zebra-Med's CCS improved sensitivity and specificity of the AHA model, leading to a net 4.5% categorical risk-reclassification improvement.
RSNA/ACR Validation
Research projects involving Zebra-Med's automatic coronary calcium scoring algorithm were presented at the 2018 Radiological Society of North America (RSNA) annual meeting.
Physician Tip

Physicians should integrate HealthCCSng as an opportunistic screening tool for coronary artery calcium (CAC) from routine non-cardiac-gated CT scans, leveraging its ability to identify at-risk patients who might otherwise be undetected. The AI-generated risk categories and annotated images can aid in early intervention and preventative care pathways. Remember that the software provides a non-diagnostic analysis and the final diagnosis and clinical decision-making remain the responsibility of the radiologist, in conjunction with other patient information and professional judgment.

HealthCCSng is designed for seamless integration into existing radiology workflows through native DICOM support and connectivity with PACS and EHR systems. The cloud-based solution minimizes local footprint and allows for automatic updates of AI models. It can send analysis results and alerts directly to PACS/workstations for worklist prioritization, ensuring that critical cases are flagged efficiently without disrupting the radiologist's established workflow.

Details

Category Radiology & Imaging AI
Pricing Subscription-based; licensing agreements; historical offering of $1 per scan for its ai1 suite.
  • Subscription-based model; licensing agreements with healthcare institutions, medical device manufacturers, and software vendors
  • Historically offered its AI1 suite for a flat fee of $1 USD per scan for all current and future algorithms (as of 2017)
DeploymentCloud / On-premise / Hybrid
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

Zebra Medical Vision has received multiple FDA 510(k) clearances for its AI solutions. Specifically, the HealthCCS Device (K172983, cleared 06/13/2018) is a non-invasive post-processing software intended to evaluate calcified plaques in the coronary arteries from pre-existing heart or chest ECG-Gated/Triggered CT scans, generating reports of total risk category of coronary calcium for physician analysis and treatment. Other FDA clearances include solutions for pneumothorax (HealthPNX), intracranial hemorrhage (HealthICH), breast cancer (HealthMammo), vertebral compression fractures (VCF), and X-ray modeling for orthopedic surgery planning (HealthJoint).

Integrations
EHR Not specified
Specialties Emergency Medicine, Orthopedics, Radiology

What the Web Says

HealthCCS by Zebra Medical Vision (now part of Nanox) is an AI-powered solution designed for early detection of cardiovascular disease from CT scans. Reviews indicate it's generally seen as an innovative tool with the potential to improve patient outcomes through proactive identification of at-risk individuals, particularly for coronary artery calcification (CAC) scoring. While praised for its automation and integration capabilities, some discussions touch upon the typical challenges of AI adoption in healthcare, such as validation and workflow integration.

Overall: Positive

Strengths

  • Automated and accurate CAC scoring from existing CT scans (e.g., lung cancer screening, abdominal CTs).
  • Early identification of cardiovascular risk in asymptomatic patients.
  • Potential to improve patient outcomes through proactive intervention.
  • Streamlines workflow for radiologists by automating a previously manual or overlooked process.
  • Non-invasive and leverages existing imaging data, reducing the need for additional scans.
  • Integration capabilities with PACS and existing hospital systems.

Limitations

  • Requires careful integration into existing clinical workflows to maximize utility.
  • Physician adoption and trust in AI-driven diagnostics can be a hurdle.
  • Potential for incidental findings to increase follow-up burden if not managed properly.
  • Cost of implementation and ongoing maintenance can be a consideration for healthcare providers.
  • Need for robust validation studies in diverse patient populations.
  • Data privacy and security concerns, as with any healthcare IT solution.

Based on reviews from: Zebra Medical Vision (Nanox) official website, Healthcare IT News articles, Radiology journals and publications (e.g., Journal of Cardiovascular Computed Tomography), Industry analyst reports on AI in healthcare, Physician forums and discussions (general sentiment), Tech review sites (general AI in healthcare discussions)

Last updated: 2026-07-19

Ratings & Reviews

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Press & Coverage

FDA
HealthCCSng 510(k) Premarket Notification
The HealthCCSng device, a non-invasive post-processing software by Zebra Medical Vision, received FDA 510(k) clearance in September 2021 for evaluating calcified plaques in coronary arteries from existing non-cardiac-gated CT studies. It generates an estimated coronary artery calcium detection category to aid in cardiovascular disease risk assessment.
2021-09
Experimental and Therapeutic Medicine (via PMC)
Computational healthcare: Present and future perspectives (Review)
This review article from December 2021 lists HealthCCS by Zebra Medical Vision Ltd. as an AI-based application cleared by the FDA in 2018 for diagnosis in radiology, specifically for evaluating calcified plaques in the coronary arteries.
2021-12
BMJ Health & Care Informatics
How machine learning is embedded to support clinician decision making: an analysis of FDA-approved medical devices
An April 2021 analysis of FDA-approved medical devices utilizing machine learning highlights HealthCCS (Zebra Medical Vision) as a diagnostic tool approved in June 2018. It quantifies calcification in coronary arteries and reports a risk category based on CT scans.
2021-04
MDPI (Cancers)
Application of Artificial Intelligence Technology in Oncology: Towards the Establishment of Precision Medicine
This November 2020 article mentions HealthCCS (Zebra Medical Vision) as an AI-powered software approved by the FDA in June 2018. It is designed to evaluate calcified plaques in the coronary arteries, falling under the radiology medical specialty.
2020-11
FDA
HealthCCS 510(k) Premarket Notification
The FDA granted 510(k) clearance to HealthCCS by Zebra Medical Vision Ltd. on June 13, 2018. This device is a non-invasive post-processing software intended to evaluate calcified plaques in the coronary arteries from pre-existing heart or chest ECG-Gated/Triggered CT scans.
2018-06
HealthAidb
HealthCCS - HealthAidb
HealthCCS is an AI-powered cardiac imaging solution by Zebra Medical Vision that analyzes non-gated CT scans to detect coronary artery calcium (CAC), aiding in early cardiovascular disease diagnosis and prevention. It has received FDA 510(k) clearance and a CE mark.
2025-10
Scribd (CRC Press)
Bioinformatics Tools and Big Data Analytics For Patient Care
A February 2023 publication lists HealthCCS by Zebra Medical Vision Ltd. as a 510(k) premarket notification for a coronary artery calcification algorithm, approved in May 2018 for cardiology.
2023-02
National Institute of Health Sciences, Japan
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A Japanese regulatory report from August 2022 includes HealthCCS by Zebra Medical Vision Ltd. as an AI medical device in radiology, with an FDA approval date of June 12, 2018, for assisting in coronary artery disease diagnosis by automatically calculating coronary artery calcification scores from CT images.
2022-08

Videos

Product demos, reviews, and walkthroughs for HealthCCS.

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Frequently Asked Questions

HealthCCSng is designed to seamlessly integrate with existing Picture Archiving and Communication Systems (PACS) and Electronic Medical Records (EMR) systems. It analyzes medical imaging data from routine non-gated, non-contrast CT scans that include the entire heart of adult patients (ages 30-85) to automatically measure coronary artery calcium (CAC).
HealthCCSng has received FDA 510(k) clearance in the U.S. and holds CE Mark certification in Europe, indicating its compliance with relevant medical device regulations. While specific details on data privacy protocols like HIPAA compliance are not explicitly detailed in the provided snippets, as an FDA-cleared medical device handling patient data, it would be expected to adhere to stringent data security and privacy standards.
HealthCCSng is intended for use on patients aged 30-85 at the time the CT scan was taken. While validated in retrospective studies showing good agreement with ground truth, the device generates a risk score, and patient management, especially for low scores, depends on physician judgment and may require further testing. The system's output is an estimation of calcium quantity and category, and clinicians can adjust category bounds, suggesting that while robust, it is a tool to aid, not replace, clinical assessment.
HealthCCSng improves patient care by opportunistically detecting coronary artery calcification from routine CT scans, identifying patients at risk for cardiovascular events who might otherwise go undiagnosed. Studies have shown its value in identifying new patients with medium and high calcium levels, with patients in the highest CAC category being significantly more likely to suffer a cardiac event. It provides templated reporting to direct at-risk patients to appropriate management.
HealthCCSng's primary advantage is its ability to automatically detect and quantify CAC from *non-cardiac-gated* CT scans, leveraging existing imaging data without requiring dedicated cardiac scans. This opportunistic detection allows for early identification of cardiovascular risk in patients undergoing CT scans for other reasons. It provides both a categorical and numerical calcium score, offering flexibility in risk assessment.
The specific pricing model for HealthCCSng is not detailed in the provided information. However, there is a reimbursement pathway for the use of Nanox.AI's HealthCCSng with CPT Codes: 0721T & 0722T. This indicates that mechanisms exist for healthcare providers to seek reimbursement for services utilizing this technology.
HealthCCSng is a post-processing software tool intended to assist physicians in evaluating calcified plaques and generating risk category reports. The device output is available to radiologists as part of their standard workflow, and a list of studies with successful algorithm analysis is available for further clinical assessment by cardiologists, general practitioners, and other medical professionals. Ultimately, patient management and clinical decisions remain the responsibility of the physician, who uses the AI's output as an aid for further analysis and treatment.

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View company profile →

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