Definium Pace Select ET
GE Hualun Medical Systems Co., LtdDefinium Pace Select ET is a digital radiography system designed to produce detailed X-ray images of multiple body parts including the skull, spine, chest, abdomen, and extremities for patients of all ages. It features advanced motorized components for positioning and enhances image acquisition with options like image pasting to stitch sequential images, improving workflow and diagnostic capabilities. The system is intended for routine radiography exams and helps clinicians by providing high-quality digital X-ray images that can be easily reviewed and shared.
Intended Use
The Definium Pace Select ET is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This device is not intended for mammographic applications.
Technology
The system is a modular digital radiography X-ray system including a 2-axis motorized tube stand, elevating table, motorized wall stand, high voltage X-ray generator, wireless detectors, and an acquisition workstation. It supports DICOM networking for image review, storage, and printing. It features motorized vertical and angulation movement, auto tracking, image pasting, auto angulation, depth camera workflow, DAP software dose calculation, and an LCD touch screen console.
Performance
The device underwent comprehensive non-clinical testing including risk analysis, design reviews, unit/module verification, system verification, performance testing, safety testing, and simulated use validation. No clinical testing was included. Testing demonstrated the device to be as safe and effective as the predicate device, supporting substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/6/2024
25 days - 2
FDA Approval
10/1/2024
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