Definium Tempo Select

by GE Hualun Medical Systems Co.  · Based in China → — Focus on your patients, not the process
Radiology
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Regulatory Status Disclosed

Overview

Definium™ Tempo Select, manufactured by GE Hualun Medical Systems Co., Ltd., is an advanced, highly-automated, AI-powered digital X-ray system, not a physician directory tool. It is designed to streamline exam workflows, decrease physical stress on technologists, and improve efficiency in radiology departments. The system features intelligent applications, including a 12-inch touchscreen at the tube head for in-room workflow control and automated component positioning to reduce manual work.

Equipped with an Intelligent Workflow Suite that combines computer vision, video analytics, and precision engineering, Definium Tempo Select offers features like Position Assist, Technique Assist, Collimation Assist, and Patient Snapshot to help avoid retakes and ensure accurate imaging. It utilizes high-quality FlashPad™ Select detectors and AI-powered advanced image processing software (Helix™ 3.0, including AIBC, AITE, LCE, DPNR algorithms) to reduce variability and provide optimal image quality for confident clinical diagnostic decisions. The system is intended for generating digital radiographic images of various body parts in patients of all ages and supports DICOM network integration for image management.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Highly automated, AI-powered digital X-ray system
  • Streamlined exam workflows and reduced physical strain for technologists
  • Automated component positioning and motorized OTS angulation
  • In-room workflow control via 12-inch tube head touchscreen
  • Intelligent Workflow Suite (computer vision, video analytics, precision engineering)
  • Position Assist, Technique Assist, Collimation Assist, Patient Snapshot features
  • AI-powered advanced image processing software (Helixu2122 3.0, AIBC, AITE, LCE, DPNR)
  • FlashPadu2122 Select detectors for high-resolution, dose-efficient imaging
  • DICOM network integration for image review, storage, and printing
  • Built-in security features (anti-virus, intrusion detection, data encryption, firewall)

Use Cases

  • Routine radiography exams (skull, spinal column, chest, abdomen, extremities)
  • Reducing technologist physical strain and workload in radiology departments
  • Improving image quality and consistency for diagnostic confidence
  • Minimizing errors and repeat X-ray exams
  • Optimizing radiology department workflow and operational efficiency
  • Image pasting function for stitching sequential radiographs into a single image

What Physicians Need to Know

DICOM Support & Standards
Supports DICOMu00ae capture for images and patient snapshots. Includes built-in security features such as data encryption and storage. GE Healthcare provides DICOM Conformance Statements for related X-ray systems.
PACS Integration Method
DICOM-based integration, allowing the system to optionally attach a 'Patient Snapshot' as a secondary DICOMu00ae capture when sent to PACS, providing additional context to the radiologist.
Reading Room Workflow Impact
For technologists, the highly automated and motorized system reduces physical strain and manual work, with in-room workflow control via a 12-inch touchscreen console. The AI-powered Intelligent Workflow Suite (Position Assist, Technique Assist, Collimation Assist, Patient Snapshot) minimizes errors and retakes, while AutoRAD automates protocol and collimation selection. Live streaming video aids patient monitoring. For radiologists, AI-powered Helixu2122 3.0 advanced image processing provides consistent, high-quality images with clarity, contrast, and resolution, enhancing diagnostic confidence, and Patient Snapshot offers additional contextual information.
AI Model Architecture (deep learning approach)
Utilizes Helixu2122 3.0 advanced image processing, which incorporates AI-powered algorithms such as Artificial Intelligence Brightness and Contrast (AIBC) and Artificial Intelligence Tissue Equalization (AITE). The AI Tissue Equalization feature specifically leverages a Deep Learning AI model.
Processing Speed (per study)
For Angulated Auto Image Paste, image acquisition takes less than 13 seconds, and a fully stitched image appears in less than 22 seconds for a 35.4 cm (13.9 in) coverage area.
FDA Clearance Pathway (510k/De Novo)
Received 510(k) clearance (K250788).
Supported Modalities (CT/MRI/X-ray/US)
Digital X-ray system, intended to generate radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages.
Sensitivity & Specificity Data
Specific sensitivity and specificity data for the AI algorithms are not explicitly provided in the available information. However, verification and validation testing confirmed that the AI Tissue Equalization algorithm meets performance criteria.
RSNA/ACR Validation
The Definiumu2122 Tempo Select was featured at RSNA 2025.
Physician Tip

Leverage the AI-powered Helixu2122 3.0 advanced image processing for consistent, high-quality images, which can enhance diagnostic confidence by minimizing variability. Utilize the Patient Snapshot feature, delivered via DICOM, to gain additional contextual information for each X-ray study. The automated workflow features, while primarily for technologists, contribute to more consistent image acquisition, ultimately benefiting diagnostic accuracy.

Definium Tempo Select integrates with existing PACS via DICOM, allowing for seamless transfer of images and patient snapshots. The system also features a common user interface across GE HealthCare X-ray systems, which can simplify training and cross-system operation within a facility. Built-in security measures, including data encryption and storage, are designed to protect patient data and ensure secure interconnection to external storage.

Details

Category Radiology & Imaging AI
Pricing Contact vendor for pricing — N/A
DeploymentOn-premise (X-ray system hardware)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

Definium Tempo Select received FDA 510(k) Premarket Notification (K250788) as a Class II medical device (Stationary X-Ray System, Product Code KPR). It is cleared for generating digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages.
Integrations
EHR Not specified
Specialties Radiology

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Ease of Use
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Support & Docs
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Press & Coverage

Signify Research
X-ray Market & RSNA 2025: Key Updates and Trends
GE HealthCare showcased its new Definium Tempo Select ceiling DR system at RSNA 2025, highlighting its integration of high-end automation into a budget-friendly, FDA-cleared, and commercially available system. The system features auto-stitching, camera-based workflow, and a more affordable flat panel detector.
2025-12
AuntMinnie
GE HealthCare features new MRI scanners, PCCT system
At RSNA 2025, GE HealthCare highlighted the Definium Tempo Select, a new overhead tube suspension system for digital X-ray, alongside the floor-mounted Definium Pace Select ET. Both systems feature automation tools designed to reduce workflow steps and image variability.
2025-12
GE HealthCare
News Brief: X-ray | GE HealthCare (United States)
Definium Tempo Select was designed to meet the increasing demand for high-quality imaging solutions that are both affordable and user-friendly.
unknown
GE HealthCare
Definium Tempo Select | GE Healthcare
The Definium Tempo Select is an advanced, highly-automated overhead tube suspension (OTS) digital X-ray system designed to streamline workflows and reduce physical strain on technologists. It features automated component positioning, in-room workflows, and AI-powered advanced image processing software for optimal image quality.
2025-08
Recyclemedica.com
GE Healthcare Unleashes a Wave of New Products: MRI, PCCT, and AI Imaging Upgraded Across the Board!
GE HealthCare showcased the new ceiling-mounted Definium Tempo Select X-ray system at RSNA 2025, alongside the floor-mounted Definium Pace Select ET, both featuring workflow-reduction and image-consistency tools.
2025-12
accessdata.fda.gov (FDA)
August 28, 2025 GE Hualun Medical Systems Co., Ltd Ma Kenny Manager, Regulatory Affairs - WHXR No.1, Yong Chang North Road, - accessdata.fda.gov
The FDA document details the Definium Tempo Select's intended use for generating digital radiographic images of various body parts in patients of all ages, excluding mammographic applications. It also mentions updates to the Tissue Equalization feature with a Deep Learning AI model for consistent image presentations.
2025-08
GE HealthCare
RSNA Press Kit | GE HealthCare (United States)
GE HealthCare's RSNA 2025 press kit includes information and images for the Definium Tempo Select, highlighting it as one of their featured products.
unknown
GE HealthCare
DEFINIUM TEMPO SELECT - GE Healthcare
This document provides site readiness information for the Definium Tempo Select, outlining environmental specifications, customer responsibilities for installation, and disclaimers regarding construction purposes.
2026-04

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Frequently Asked Questions

Definium Tempo Select integrates AI-powered features like the Intelligent Workflow Suite, Position Assist, and Technique Assist to automate tasks, reduce errors, and streamline the imaging process. This helps technologists achieve consistent, high-quality images and allows them to focus more on patient care.
Definium Tempo Select includes built-in security features such as anti-virus protection, host-based intrusion detection, and data encryption to safeguard against cyber threats. The AI Tissue Equalization feature has undergone FDA clearance processes, and the system complies with the Unique Device Identification (UDI) Rule.
Definium Tempo Select is not intended for mammographic applications, and its commercial availability and specific features may vary by market. Patient coverage can also depend on the thickness and distance from the detector to the patient.
Within GE HealthCare, systems like Definium Tempo, Definium Pace Select, and Definium 656 HD offer similar digital X-ray capabilities, some with AI enhancements. While other manufacturers produce digital radiography systems, direct AI feature comparisons would require specific product evaluations.
Definium Tempo Select is designed for a low total cost of ownership (TCO), attributed to reduced training needs, high system uptime, and minimal maintenance and repair expenses. Upgrade packages are also available for existing Definium Tempo users at a fraction of the cost of a new system.
The system includes features like data encryption and secure interconnection to external storage to protect patient information. While it generates diagnostic radiographic images that can be sent through a DICOM network for review, storage, and printing, specific details on secondary use of data by the AI models are not explicitly detailed beyond the retrospective collection for algorithm verification.

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