Spectral CT 7500 RT
Philips Medical Systems Technologies Ltd.The Spectral CT 7500 RT is an advanced computed tomography (CT) system that uses dual-layer detector technology to acquire high and low energy X-ray data simultaneously. This allows it to generate detailed cross-sectional images and analyze the chemical composition of tissues and contrast agents. It supports applications in radiology, cardiology, oncology, and radiation therapy planning, helping clinicians visualize and assess anatomical and pathological structures more accurately.
Intended Use
The Spectral CT 7000 family is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. It provides images and material composition information using dual-energy spectral data for visualization and analysis of anatomical and pathological structures in patients of all ages. It is used in radiology, interventional radiology, cardiology, oncology, and radiation therapy planning.
Technology
The device consists of a rotating gantry CT scanner system with a dual-layer spectral detector that acquires simultaneous high and low energy X-ray data, allowing generation of monoenergetic images, material density maps, and effective atomic number images. It includes software components for spectral reconstruction and image viewing. The design is substantially equivalent to the predicate Spectral CT system but includes new features such as pulmonary gated 4D CT scanning and extended field of view for radiation therapy planning.
Performance
Non-clinical performance testing according to multiple international standards and FDA guidance documents was conducted, including system-level verification, validation, and image quality testing of new features like pulmonary gating and extended field of view. External expert clinical image reviews confirmed image quality is acceptable for radiation therapy planning. The device meets all performance and safety criteria without raising new concerns compared to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/27/2024
6 months - 2
FDA Approval
10/18/2024
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