3DXR

by GE Medical Systems SCS  · Based in United States → — AI-powered 3D Reconstruction for Enhanced Interventional X-ray Imaging
Interventional Radiology Radiology Vascular Surgery

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Regulatory Status Disclosed

Overview

3DXR is a post-processing software application developed by GE Medical Systems SCS, a part of GE HealthCare. It is designed to perform three-dimensional (3D) reconstruction of images acquired through 3D acquisition modes of X-ray interventional systems. The software incorporates a Deep-Learning option, CleaRecon DL, which utilizes a convolutional neural network to significantly reduce streak artifacts around contrasted vessels and stents, as well as motion and metal artifacts. This enhancement in image clarity assists physicians in critical tasks such as diagnosis, surgical planning, interventional procedures (including liver, prostate, neuro, and endovascular aortic repair), and treatment follow-up. Running on the Advantage Workstation platform, 3DXR provides advanced visualization capabilities for reconstructed volumes, improving precision and confidence in clinical decision-making.

Note: This tool is a radiology imaging software and is NOT designed for physician directory services.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Deep-Learning (CleaRecon DL) for streak artifact reduction
  • Motion artifact reduction
  • Metal artifact reduction
  • Three-dimensional (3D) image reconstruction
  • Advanced visualization with Volume Viewer
  • Integration with X-ray interventional systems (e.g., Allia IGS, Innova IGS)
  • DICOM compliance for image import/export
  • Augmented reality-based interventional radiology suite (broader platform feature)
  • Holographic heads-up display streaming live medical imaging (broader platform feature)
  • 3D anatomy model visualization

Use Cases

  • Assisting physicians in diagnosis
  • Surgical planning
  • Guiding interventional procedures (e.g., liver, prostate, neuro, endovascular aortic repair)
  • Treatment follow-up
  • Spinal and orthopedic procedures
  • Enhancing image clarity in cone-beam CT (CBCT) images

What Physicians Need to Know

PACS Integration Method
3DXR operates on the Advantage Workstation, which uses DICOM services for image exchange. GE HealthCare also offers solutions like 'Open AI Orchestrator' designed for seamless integration of AI-based clinical imaging applications into GE HealthCare PACS workflows, including True PACS and Centricity PACS, to manage and orchestrate radiology workloads.
Reading Room Workflow Impact
The Deep-Learning option, CleaRecon DL, within 3DXR, is designed to enhance image clarity by reducing streak artifacts, thereby assisting physicians in diagnosis, surgical planning, interventional procedures, and treatment follow-up. Clinical testing demonstrated improved image clarity in 98% of cases and increased confidence in CBCT image interpretation in 94% of cases. GE HealthCare's AI tools generally aim to streamline workflows by automating repetitive tasks and improving efficiency.
AI Model Architecture (deep learning approach)
3DXR incorporates CleaRecon DL, a Deep-Learning algorithm based on a convolutional neural network. This deep learning technology is specifically designed to remove streak artifacts around contrasted vessels and stents, and also includes features for motion and metal artifact reduction.
Processing Speed (per study)
Specific 'per study' processing speed data for 3DXR or CleaRecon DL was not explicitly detailed in the provided search results. However, GE HealthCare's other AI-powered reconstruction algorithms, such as AIR Recon DL for MRI, have shown reductions in scan times by 30-50%, and Sonic DL for 3D is designed to reduce scan times by up to 86%.
FDA Clearance Pathway (510k/De Novo)
The CleaRecon DL option for 3DXR received U.S. FDA 510(k) clearance. The 3DXR application itself is a post-processing software, and the addition of the CleaRecon DL option triggered a 510(k) submission as a modification to the predicate 3DXR device.
Supported Modalities (CT/MRI/X-ray/US)
3DXR is designed for three-dimensional (3D) reconstruction of images acquired with 3D acquisition modes of X-ray interventional systems, specifically utilizing cone-beam CT (CBCT) images from an interventional X-ray system. It parses X-Ray Image Storage and generates CT Image Storage DICOM objects.
Sensitivity & Specificity Data
For CleaRecon DL, clinical testing with 110 patient exams across multiple anatomies confirmed improved image clarity in 98% of cases without introducing artificial structures or hiding important anatomical features. A survey indicated that 98% of CBCT images reconstructed with CleaRecon DL were clearer than conventional images, and it improved CBCT image interpretation confidence in 94% of cases. These metrics reflect image quality enhancement rather than diagnostic detection sensitivity/specificity for specific pathologies.
RSNA/ACR Validation
CleaRecon DL has received 510(k) clearance and CE mark, and its launch and capabilities have been announced and showcased by GE HealthCare at events like RSNA. GE HealthCare frequently presents its AI innovations at RSNA, indicating industry recognition and presentation of its capabilities.
Physician Tip

Leverage 3DXR with CleaRecon DL for interventional X-ray procedures to significantly improve image clarity and reduce streak artifacts in CBCT images, potentially enhancing diagnostic confidence and precision in surgical planning and treatment follow-up. The deep learning algorithms aim to provide clearer images in challenging cases, which can be particularly beneficial for complex anatomies and procedures involving contrasted vessels and stents. Integrate this tool within your existing Advantage Workstation and PACS environment to optimize workflow efficiency.

3DXR runs on the Advantage Workstation platform and utilizes standard DICOM services for image input and output, ensuring compatibility with existing imaging infrastructure. While 3DXR itself does not have intrinsic DICOM network features, its operation within the Advantage Workstation allows for seamless integration into PACS environments. GE HealthCare's broader 'Open AI Orchestrator' and True PACS solutions further facilitate the integration of AI-enabled tools into radiology workflows, supporting interoperability with various systems and potentially third-party AI applications.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Contact vendor
DeploymentOn-premise (runs on GE's Advantage Workstation platform)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

3DXR received U.S. FDA 510(k) clearance (K243446) on February 25, 2025. It is cleared for performing 3D reconstruction computation of images acquired with 3D Acquisition modes of X-ray interventional systems for visualization under Volume Viewer, with the CleaRecon DL option for artifact reduction.

Integrations
EHR Not specified
Specialties Interventional Radiology, Radiology, Vascular Surgery

Ratings & Reviews

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Ease of Use
Integration
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Press & Coverage

GE HealthCare
GE HealthCare Introduces Image Guiding Solution Upgrades
GE HealthCare has introduced Allia platform upgrade pathways, including CleaRecon DL, an AI-enabled deep learning reconstruction technology for CBCT images, and 3DStent, an intraprocedural tool for 3D visualization of coronary stents. These upgrades are designed to enhance image quality, expand imaging capabilities, and streamline workflows across various systems.
2026-07
GE HealthCare
GE HealthCare spotlights its innovation renaissance designed to advance precision care at ECR 2026
GE HealthCare showcased seven significant innovations at ECR 2026, including Pristinau2122 Recon DL, an advanced 3D mammography image reconstruction technology combining deep learning with iterative reconstruction. These innovations aim to advance imaging performance, operational efficiency, and diagnostic confidence.
2026-03
medRxiv
3D-DXA Cortical and Trabecular Parameters; Agreement and Precision Between GE Healthcare Prodigy and iDXA Densitometers | medRxiv
This study assessed the agreement and precision of 3D-DXA cortical and trabecular femur parameters between GE Healthcare Prodigy and iDXA densitometers. The findings indicate strong agreement between devices and comparable short-term precision, suggesting no adjustment is needed when using 3D-DXA with these densitometers.
2026-03
GE HealthCare
FDA Grants Clearance to GE HealthCare's AI-Enabled Auto-Contouring Software
GE HealthCare received FDA 510(k) clearance for MIM Contour Protu00e9gu00e9AI+ 2.0, an AI-enabled auto-contouring software for radiation oncology treatment planning. This software aims to reduce treatment planning time and expand clinical capabilities with new models, including a Magnetic Resonance Brain model.
2026-06
GE HealthCare
GE HealthCare Showcases AI-Powered MRI Technologies
At ISMRM 2026, GE HealthCare announced advancements in research tools and MRI systems, including the U.S. FDA 510(k) pending status of Sonic DL for 2D imaging beyond cardiac cine. This technology aims to accelerate MRI scans and improve image quality.
2026-05
Medical Device Network
GE HealthCare submits deep learning tech for FDA clearance - Medical Device Network
GE HealthCare submitted a 510(k) application to the FDA for CleaRecon DL, a deep learning technology that uses AI-based 3D reconstruction to improve cone-beam computed tomography (CBCT) images. This technology is intended to remove streak artifacts and will be available for GE HealthCare's Allia systems.
2024-12
GuruFocus
GE HealthCare Technologies Inc (GEHC) Unveils Sonic DL for 3D: R - GuruFocus
GE HealthCare announced the launch of Sonic DL for 3D, a deep learning technology designed to accelerate MRI scans across various clinical applications, including brain, spine, orthopedic, and body exams. This innovation aims to reduce scan times by up to 86% and enhance image resolution.
2024-12
GE HealthCare
3DXR DICOM Conformance Statement - GE Healthcare
The 3DXR 3.0 DICOM Conformance Statement outlines the capabilities of the 3DXR software, which is installed on the Advantage Workstation for examination review and diagnosis. It supports DICOM services for importing and exporting images and radiotherapy data.
2024-09

Videos

Product demos, reviews, and walkthroughs for 3DXR.

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Frequently Asked Questions

GE Healthcare's 3DXR is a post-processing software application designed to integrate with X-ray interventional systems, performing three-dimensional reconstruction of images obtained through 3D acquisition modes. It enhances visualization for diagnosis, surgical planning, interventional procedures, and treatment follow-up by providing clearer 3D models.
GE Healthcare's 3DXR has received FDA 510(k) clearance for its intended use in 3D reconstruction of X-ray images. As a medical device software, it is designed to comply with data privacy regulations such as HIPAA, employing robust encryption and access controls to protect patient information.
Alternatives might include other 3D reconstruction software or traditional 2D imaging with mental 3D interpretation. 3DXR's unique advantage lies in its Deep-Learning option, CleaRecon DL, which significantly reduces streak artifacts and enhances image clarity, aiding in more precise clinical decisions.
While specific pricing details are not publicly available, software like 3DXR typically involves an initial licensing fee for the Advantage Workstation platform and the 3DXR application. This may be followed by recurring costs for software updates, maintenance, and ongoing technical support.
Optimal performance of 3DXR requires images acquired with 3D acquisition modes of X-ray interventional systems and runs on the Advantage Workstation platform. While its Deep-Learning algorithm effectively reduces streak artifacts, users should be aware of its specific scope and the types of artifacts it is designed to address.
Clinical testing with 110 patient exams confirmed improved image clarity in 98% of cases without introducing artificial structures or hiding important anatomical features. Engineering bench tests also demonstrated that the CleaRecon DL algorithm effectively reduces streak artifacts, with a significant reduction in mean absolute error.

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