Revolution Ascend
GE Healthcare Japan CorporationThe Revolution Ascend is a CT scanner designed to generate detailed cross-sectional images of various body parts including the head, whole body, cardiac, and vascular areas. It uses x-ray transmission data taken at different angles and planes. The device supports multiple acquisition modes and post-processing of images, aiding clinicians in diagnosing disease, trauma, and abnormalities, as well as planning and monitoring therapy.
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, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
Technology
The Revolution Ascend uses a 75 cm gantry bore, 64-row detector, and supports multiple scan modes (Axial, Cine, Helical, Cardiac, Gated). It includes image acquisition and reconstruction hardware/software, general system software, and an operator console. A design change involves an alternative detector scintillator material with identical system performance. It also incorporates Deep Learning Iterative Reconstruction (DLIR) technology cleared previously.
Performance
The device underwent risk analysis, design reviews, unit and integration testing, performance and safety verification, simulated use testing, and image quality evaluations based on IEC and NEMA standards. Bench tests demonstrated image quality equivalence between the modified detector (Merc40H) and the predicate device with the original detector (Merc40L). The DLIR performance was re-substantiated. Non-clinical tests showed that the device performs equivalently to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/16/2021
1 month - 2
FDA Approval
2/4/2022
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