Spectral CT
Philips Medical Systems Technologies Ltd.The Spectral CT system by Philips is an advanced CT scanner that acquires dual-energy X-ray data to provide detailed cross-sectional images of the body. This technology enables the analysis of different materials' chemical composition and improves visualization of anatomical and pathological structures, aiding clinicians in diagnostic imaging and treatment planning across multiple clinical areas including radiology, cardiology, and oncology.
Intended Use
The Spectral CT system 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 acquires dual-energy CT data for material decomposition, providing detailed imaging for diagnostic purposes in radiology, cardiology, oncology, and radiation therapy planning, including low dose lung cancer screening.
Technology
The Spectral CT system consists of a scanner with rotating gantry, patient couch, operator console, plus a spectral reconstruction system and viewer. It acquires dual-energy spectral data using a dual-layer detector allowing material differentiation based on energy attenuation differences. It shares fundamental technology with previously cleared predicate devices, with added features like pulmonary gating (4DCT) and extended field of view (up to 800mm).
Performance
Non-clinical performance testing was conducted per international standards (IEC 60601 series, ISO 14971, IEC 62304, etc.), demonstrating the system meets safety and effectiveness requirements. Validation included software verification, phantom-based image quality assessments, and clinical image evaluation to support the device's safety and substantial equivalence to predicates.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/26/2024
4 months - 2
FDA Approval
5/16/2025
Other devices from Philips Medical Systems Technologies Ltd.
- Spectral CT 7500 RT2024 • 510K
- Illumeo System2018 • 510K
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