Philips Incisive CT
Philips Healthcare (Suzhou) Co., Ltd.The Philips Incisive CT is an advanced whole-body computed tomography system used to acquire detailed images of the head, body, heart, and vascular structures. It helps clinicians diagnose various conditions and supports low-dose lung cancer screening, improving patient care by providing high-quality diagnostic images efficiently.
Intended Use
The Incisive CT 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. Indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. Used for diagnostic imaging and for low dose CT lung cancer screening for early detection of lung nodules that may represent cancer within approved protocols.
Technology
The Philips Incisive CT features a continuously rotating x-ray tube, detectors, and gantry with multi-slice capability; a 72cm bore and 50cm scan field of view. Images are generated by computer reconstruction of x-ray transmission data from various angles and planes. It includes hardware and software for data acquisition, image display, manipulation, storage, and post-processing.
Performance
The device met all acceptance criteria in non-clinical performance tests, including design verification, validation, and consensus standards testing (electrical safety, usability, radiation protection, dose management). Clinical data was not required due to substantial equivalence to predicate devices. The risk management confirmed no new or unmitigated risks.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/4/2021
8 months - 2
FDA Approval
4/27/2022
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