Philips CT 3500
Philips Healthcare (Suzhou) Co., LtdThe Philips CT 3500 is a computed tomography X-ray system designed to produce detailed images of the head, whole body, cardiac, and vascular regions. It supports diagnostic imaging and low dose lung cancer screening using advanced imaging features and includes AI-based image reconstruction for improved image quality at reduced dose, helping clinicians with early detection and diagnosis.
Intended Use
The Philips CT 3500 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 (Cardiac Calcium Scoring), and vascular applications in patients of all ages and supports low dose CT lung cancer screening for early detection of lung nodules.
Technology
Philips CT 3500 is a whole-body CT X-ray system featuring a continuously rotating X-ray tube, detectors, gantry with multi-slice capability, and a 72cm bore with a 50cm scan field of view. It uses advanced hardware and software including a trained deep learning neural network for noise reduction and low dose image reconstruction, and supports multiple scan modes including viewing and post-processing functions.
Performance
The device was tested extensively per international and FDA-recognized standards including IEC 60601 family, NEMA standards, and FDA guidance on software and cybersecurity. Verification and validation testing, including image quality comparisons to predicate devices, demonstrated that Philips CT 3500 meets acceptance criteria for safety and effectiveness. No clinical study was required due to substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/28/2022
1 month - 2
FDA Approval
12/22/2022
Other devices from Philips Healthcare (Suzhou) Co., Ltd
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- CT 53002024 • 510K
- Philips Incisive CT2022 • 510K
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