Philips iCT CT system
Philips Medical Systems Nederland B.V.The Philips iCT CT System is a computed tomography scanner designed for diagnostic imaging of the head, body, cardiac, and vascular regions. It produces detailed cross-sectional images by reconstructing X-ray data taken from multiple angles, aiding clinicians in diagnosing a range of conditions. The system offers updated hardware and software improvements for enhanced image quality, cybersecurity, and usability without altering its core imaging capabilities.
Intended Use
The Philips iCT CT system 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. Intended also for low dose CT lung cancer screening for early detection of lung nodules.
Technology
The system features a continuously rotating X-ray tube and multi-slice detector gantry acquiring transmission data at multiple angles and planes, using advanced image reconstruction algorithms. It maintains the same fundamental scientific technology as predicate device K162838, with hardware and software updates for improved performance, cybersecurity, and usability.
Performance
Performance testing included extensive non-clinical verification and validation such as cybersecurity testing, electromagnetic compatibility, electrical safety, biocompatibility, usability validation according to IEC standards, and automated image quality assessments with phantoms. Results confirmed the modified device performs equivalent to the predicate with no new safety risks.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/4/2025
3 months - 2
FDA Approval
6/27/2025
Other devices from Philips Medical Systems Nederland B.V.
- AV Viewer2025 • 510K
- Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems2025 • 510K
- Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System2025 • 510K
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