Revolution Ascend Sliding

The Revolution Ascend Sliding system is an advanced computed tomography device engineered to enhance clinical workflow by employing a gantry that moves on rails around a stationary patient, thereby facilitating integrated in-room imaging and procedures. Its methodology relies on X-ray transmission data acquisition across multiple planes and subsequent computer reconstruction, maintaining the core imaging science and performance of its predicate while introducing an innovative patient-gantry interaction specifically beneficial for interventional radiology and radiation oncology applications.

The Revolution Ascend Sliding is a computed tomography (CT) X-ray system designed for head, whole-body, cardiac, and vascular imaging applications across all patient ages. It comprises a gantry, a transporter system, an operator console with a host computer, a power distribution unit, and associated hardware/software for image acquisition and reconstruction. The system generates cross-sectional images by computer reconstruction of X-ray transmission data obtained from various angles and planes, supporting modes such as Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions, with or without contrast media. It also includes capabilities for signal analysis, image display, and post-processing to produce images in diverse trans-axial and reformatted planes, aiding in the diagnosis, planning, guidance, and monitoring of medical conditions and therapies. The primary technological distinction of the Revolution Ascend Sliding from its predicate device is its gantry mobility. Instead of a traditional moving patient table, this system features a gantry mounted on a transporter that allows linear movement on rails. This design enables the gantry to scan the patient, who remains on a stationary support, thereby facilitating an improved clinical workflow, particularly in interventional radiology and radiation oncology settings. This innovation allows for both CT imaging and treatment procedures to occur in the same room without requiring patient transfer, while maintaining identical intended use, indications for use, and equivalent imaging performance and quality specifications to the predicate device. Key components include a 75cm bore, Performix 40 Plus X-Ray Tube, JEDI60DC High Voltage Generator, and Merc40H detector, though the physical gantry tilt feature is disabled.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What are the specific mechanical and operational differences in the transporter rail system of the Revolution Ascend Sliding compared to the gantry movement mechanisms in the reference device (K091673), and how do these impact long-term reliability and maintenance schedules?; How does the stationary patient setup combined with the moving gantry affect image registration accuracy and potential for motion artifacts during procedures requiring precise targeting, such as biopsies or radiotherapy planning, compared to traditional moving table systems?; What are the radiation safety implications, specifically concerning scatter radiation patterns and occupational dose to clinical staff, resulting from the sliding gantry design during combined imaging and interventional procedures within the CT suite?; Given that the physical tilt feature of the gantry is disabled in the Revolution Ascend Sliding, what alternative imaging techniques or software-based reconstruction methods are employed to achieve oblique or angled views, and how does this affect diagnostic image quality for specific anatomical regions or clinical scenarios?; What ergonomic assessments and quantitative workflow studies were conducted to validate the claimed improvements in clinical efficiency for interventional radiology and radiation oncology, particularly concerning procedure time, patient handling, and room turnover?