Revolution Ascend Sliding
GE Hangwei Medical Systems Co., Ltd.The Revolution Ascend Sliding is a CT X-ray system designed to generate detailed cross-sectional images of the body, including head, whole body, cardiac, and vascular areas. Uniquely, it features a gantry mounted on a transporter allowing linear movement on rails, improving patient workflow by enabling imaging and treatment procedures in the same room without moving the patient. It supports a range of acquisition modes and image processing features to aid clinicians in diagnosis and therapy monitoring.
Intended Use
The system is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages, supporting diagnosis and therapy planning.
Technology
The device consists of a gantry mounted on a transporter for linear movement on rails, image acquisition and reconstruction hardware/software, and system software. It performs Axial, Cine, Helical, Cardiac, and Gated acquisition modes. The gantry remains similar to the predicate device but disables physical tilt, with other components such as X-ray tube, detector, and high voltage generator retained. It uses backlit diode detector technology and GE low noise ASICs for signal conversion.
Performance
The device underwent extensive non-clinical verification and validation testing, including risk management, software verification, dose specification and image quality testing per IEC standards. Non-clinical bench tests showed performance equivalent to the predicate device. Clinical testing was not required since engineering bench tests were sufficient.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/22/2023
3 months - 2
FDA Approval
2/22/2024
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