The CT 5300 by Philips Healthcare is an advanced computed tomography system designed to produce detailed cross-sectional images of the head, body, cardiac and vascular structures. It supports various CT applications including diagnostic and low-dose lung cancer screening. The system uses AI-enhanced image reconstruction to provide high quality images at reduced radiation dose, helping clinicians detect and analyze anatomical features and abnormalities.
Intended Use
The CT 5300 is a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. It is indicated for head, whole body, cardiac and vascular CT applications in patients of all ages. It is intended for diagnostic imaging and for low dose CT lung cancer screening for early detection of lung nodules.
Technology
The device is a whole-body CT X-Ray system featuring continuously rotating X-ray tube, detectors, and gantry with multi-slice capability. Key components include gantry with X-ray tube, high voltage generator, data management system, patient table, and console. It supports advanced reconstruction algorithms including AI-enabled Precise Image, Precise Cardiac, and Precise Position modules for enhanced image quality and workflow automation.
Performance
Performance testing included conformance to international standards (e.g., IEC 60601 series), FDA recognized consensus standards, NEMA standards, and FDA guidance documents. Verification and validation demonstrated compliance and adequate performance. Clinical image quality assessment confirmed that AI-based Precise Image reconstruction at half dose was comparable or superior to full dose predicate images. The Precise Position AI algorithm was validated for multiple exams. No new clinical studies were required due to substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/17/2023
8 months - 2
FDA Approval
5/3/2024
Other devices from Philips Healthcare (Suzhou) Co., Ltd.
- CT Collaboration Live2024 • 510K
- Philips CT 35002022 • 510K
- Philips Incisive CT2022 • 510K
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