Xeleris V Processing and Review System

by GE Healthcare  · Based in United States → — Virtually transforming the way you work.
Nuclear Medicine Radiology
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Enterprise, quotation-based
Regulatory Status Disclosed

Overview

The Xeleris V Processing and Review System by GE Healthcare is a virtual, AI-powered solution designed to transform nuclear medicine workflows. It removes the limitations of traditional dedicated workstations by offering a mobile, scalable, and accessible thin-client environment for processing, reviewing, and reporting nuclear medicine images. Leveraging advanced AI applications powered by GE’s Edison platform, Xeleris V provides automated deep learning-based organ segmentation and quantitation for SPECT/CT and PET/CT data. This system enhances efficiency and precision in tasks like preoperative functional assessment of lung cancer, pulmonary embolism evaluation, and nuclear oncology dosimetry calculations. Available through outright purchase or a Smart Subscription service, Xeleris V ensures systems are synchronized and always up-to-date with the latest software and clinical applications.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Virtual processing and review solution for nuclear medicine
  • AI-enabled clinical applications (Q.Volumetrix AI, Q.Lung AI, Q.Thera AI, EXINI Bone, Q.Liver)
  • Mobile, scalable, and accessible thin-client solution
  • Removes restraints of a dedicated processing and review workstation
  • Smart Subscription for automatic updates and synchronization
  • Automated deep learning-based organ segmentation and quantitation
  • Supports SPECT/CT and PET/CT data
  • Image processing, review, and reporting of nuclear medicine images
  • Data display, quality control, image manipulation, quantification analysis, transfer, storage, and printing
  • Secure access to data from anywhere

Use Cases

  • Nuclear Medicine Processing and Review
  • Preoperative Functional Assessment of Lung Cancer
  • Pulmonary Embolism Evaluation
  • Nuclear Oncology (Quantitation and Dosimetry)
  • Bone Metastases from Prostate Cancer (EXINI Bone)
  • Brain, Lung, Cardiac, Liver, and Bone Imaging Analyses

What Physicians Need to Know

DICOM Support & Standards
Xeleris V is a nuclear medicine software system designed for digital processing, review, and reporting of medical images, including NMI data, planar and tomographic scans, and multimodality imaging fusion with CT or MR. This functionality inherently relies on and supports DICOM standards for image handling and exchange within a medical imaging environment.
PACS Integration Method
Xeleris V is a virtual, thin-client, and scalable solution that eliminates the need for dedicated workstations. It allows access to imaging data across an entire network, bringing data together in a centralized, virtual location, likely integrating with PACS or VNA systems via standard network protocols.
Reading Room Workflow Impact
Transforms nuclear medicine workflow by providing greater mobility, flexibility, and access to applications from various locations. It streamlines workflows, automates time-consuming tasks like organ segmentation and quantitation, and reduces manual clicks, aiming to improve efficiency and address physician burnout.
AI Model Architecture (deep learning approach)
Leverages advanced AI applications powered by GE's Edison platform, utilizing automatic deep learning-based approaches for tasks such as organ segmentation and quantitation. Specific applications like Q. Lung AI use deep learning for SPECT/CT lung lobe segmentation.
Processing Speed (per study)
AI-enabled applications significantly reduce user time and clicks. Q. Thera AI demonstrated an average reduction of 58% in the time required for the user to process and calculate dose, and AI-enabled lung segmentation reduced the number of clicks by an average of 57%.
FDA Clearance Pathway (510k/De Novo)
Cleared through the 510(k) premarket notification pathway as a Class II medical device. The initial clearance was K201103, with subsequent modifications like K221680 introducing new applications.
Sensitivity & Specificity Data
For its AI-enabled lung segmentation, Xeleris V demonstrated an overall success rate of 89%.
RSNA/ACR Validation
No explicit information regarding RSNA/ACR validation was found in the provided search results.
Physician Tip

Leverage Xeleris V's virtual and mobile access to review and process nuclear medicine studies from various locations, enhancing flexibility and reducing reliance on fixed workstations. Utilize the deep learning-based AI applications for automated organ segmentation, quantitation, and dosimetry calculations to significantly reduce manual effort and improve consistency. This allows for more time to focus on patient care and complex case interpretation, while the system helps expedite diagnoses and treatment planning in nuclear oncology and other relevant areas. Pay attention to the specific success rates and performance metrics provided for individual AI applications to understand their clinical utility.

Xeleris V is designed as a thin-client, scalable solution that integrates into existing hospital networks, bringing imaging data together in a virtual environment. It is compatible with GE Healthcare's nuclear medicine cameras (e.g., 800 and 600 Series scanners) and supports multimodality image fusion with CT and MR data. The Smart Subscription service ensures the system and its AI applications are always up to date and synchronized across facilities, simplifying IT management and maintenance.

Details

Category Radiology & Imaging AI
Pricing Enterprise, quotation-based
  • Outright purchase; Smart Subscription (quotation-based, varies by facility size, deployment, and AI applications)
DeploymentCloud, on-premise, hybrid (software-as-a-solution model, virtual environment, remote server installation)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

Xeleris V Processing and Review System received FDA 510(k) clearance (K221680) on March 1, 2023, as a Class II radiological image processing system. It is a modification of a predicate device (K201103) and introduces new AI-enabled clinical applications like Q.Thera AI and Generate Planar.
Integrations
EHR Not specified
Specialties Nuclear Medicine, Radiology

What the Web Says

The GE Healthcare Xeleris V Processing and Review System is a nuclear medicine software platform designed to streamline the processing, review, and quantification of medical images from nuclear medicine, PET, and associated CT or MR scans. It aims to eliminate the need for dedicated, fixed workstations by offering a virtual, mobile, and scalable thin-client solution accessible across an entire network. The system incorporates advanced AI applications powered by GE's Edison platform to enhance workflow efficiency and accuracy, particularly in automated segmentation and quantification tasks.

Overall: Positive

Strengths

  • Eliminates the need for dedicated, fixed nuclear medicine workstations.
  • Provides secure, mobile, and flexible access to data across the network.
  • Includes cutting-edge AI applications for automated tasks like segmentation and quantitation, potentially reducing manual clicks and processing time.
  • Highly scalable for multi-user and multi-site healthcare facilities.
  • Kept 'always current' via the Smart Subscription service, ensuring access to the latest software.
  • Supports multimodality imaging fusion with CT or MR.

Limitations

  • Requires significant investment for floating licenses.
  • Some users have reported difficulties with data assignment and recognition of acquisition series names, requiring troubleshooting.
  • Older Xeleris versions may have compatibility issues with non-GE cameras, leading to tedious syncing.
  • Previous versions of Xeleris (e.g., Xeleris 4.0) had limited sharing abilities and lacked official support for custom workflow editors.
  • Data encryption is not supported in some configurations of Xeleris software.

Based on reviews from: GE Healthcare (gehealthcare.com), IntuitionLabs, FDA Radiology AI Device - X-ray Interpreter, Reddit (r/NuclearMedicine), accessdata.fda.gov, YouTube (Master Xeleris V Data Assignment: Troubleshooting Made Easy), Veterans Affairs

Last updated: 2026-07-19

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Press & Coverage

RadAI Slice
Xeleris V Processing and Review Systems | FDA Radiology AI Device - X-ray Interpreter
The Xeleris V Processing and Review System is a nuclear medicine software platform from GE Healthcare that assists physicians in processing, reviewing, and quantifying medical images from nuclear medicine, PET, and associated CT or MR scans. It supports various clinical applications, including the detection of brain diseases, lung conditions, coronary artery disease, and bone metastases, utilizing AI-based image analysis for enhanced workflow efficiency and accuracy.
2020-09
FDA
510(k) Premarket Notification - K201103
This FDA 510(k) premarket notification details the Xeleris V Processing and Review System as a modification to the predicate device, Xeleris 4.0. It introduces new clinical applications like Exini Bone and Q.Liver, and enhances existing ones, while maintaining the core functionality for processing and reviewing Nuclear Medicine and associated CT images.
2020-09
FDA
K221680 - 510(k) Premarket Notification - FDA
This FDA document, dated March 1, 2023, is a 510(k) Premarket Notification for the Xeleris V Processing and Review System, submitted by GE Healthcare. It confirms the device's substantial equivalence to its predicate, with the addition of Q.Thera AI and Generate Planar applications.
2023-03
PMC (PubMed Central)
From research to reality: The role of artificial intelligence applications in HCC care - PMC
This article highlights the integration of GE's Xeleris V Processing and Review System, specifically its Q.Liver application, in providing preparatory assistance for selective internal radiation therapy for hepatocellular carcinoma (HCC). The system aids in liver segmentation, estimation of liver-to-lung shunt value, and calculation of body surface area.
2024-04
PMC (PubMed Central)
Progress and challenges of artificial intelligence in lung cancer clinical translation - PMC
This peer-reviewed article mentions the GE Xeleris V Processing and Review System in the context of artificial intelligence applications in lung cancer. It notes the system's use with PET/CT to assess the fraction of total lung function for lung cancer resection.
2025-07
unknown
Applications of AI/ML in accelerating the development of pulmonary drug delivery system
This article lists the Xeleris V Processing and Review System from GE Healthcare with its FDA 510(k) clearance date of March 1, 2023 (K221680) in a table of AI/ML-enabled medical devices.
2023-03
FDA
Establishment Registration & Device Listing - FDA
The FDA's Establishment Registration & Device Listing for GE Healthcare includes the Xeleris V Processing and Review System as a radiological image processing system.
2026-06

Videos

Product demos, reviews, and walkthroughs for Xeleris V Processing and Review System.

View all on YouTube

Frequently Asked Questions

Xeleris V utilizes AI applications powered by GE's Edison platform to automate and enhance image processing, including deep learning-based segmentation for organs like lungs and kidneys, and quantitative analysis for SPECT/CT and PET/CT data. This streamlines workflows, reduces manual clicks, and aids in diagnostic accuracy and treatment planning.
Xeleris V is designed and manufactured under strict quality system regulations, including 21CFR 820 and ISO 13485, and has received FDA clearance (e.g., K221680). Its virtual architecture provides a high level of security and data accessibility, conforming to industry standards like IHE for interoperability.
While Xeleris V's AI applications significantly enhance efficiency, their performance can be influenced by initial image quality, and like all AI, they may have limitations in interpreting rare or atypical pathologies. Physicians must always apply their clinical judgment and not solely rely on AI outputs.
Xeleris V stands out with its integrated, advanced AI applications like Q.Volumetrix AI and EXINI Bone, offering automated segmentation and quantitation for a streamlined workflow. While other third-party software exists (e.g., MIM, Hermes), Xeleris V is primarily designed for seamless integration within the GE Healthcare ecosystem, with limited public information on extensive third-party integration outside of GE scanners.
Xeleris V can be acquired through an outright purchase or via GE Healthcare's Smart Subscription service, which ensures continuous updates and access to the latest software and applications. The pricing is quotation-based, varying by facility size, deployment, and selected AI applications, and is generally not publicly transparent.
Xeleris V is designed for seamless integration with hospital IT infrastructure, including PACS and EMR systems, utilizing standard protocols like DICOM for efficient data transfer and a unified workflow. However, it is primarily optimized for integration with GE Healthcare's nuclear medicine scanners, and extensive third-party integration outside the GE ecosystem may require additional considerations.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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