Philips iCT CT system

The Philips iCT CT System is a computed tomography X-ray system that produces cross-sectional images of the head and body by reconstructing X-ray transmission data acquired at multiple angles. It is indicated for diagnostic imaging and low-dose CT lung cancer screening in patients of all ages, supporting head, whole body, cardiac, and vascular applications.

The subject device maintains identical fundamental operating principles, scan modes (surview, helical, axial), spatial resolution, detector specifications, gantry dimensions, and imaging performance to the predicate device. Key hardware enhancements include a Harmonized Phantom Kit, Windows 10 operating system upgrade, enhanced cybersecurity (RBAC, encryption, audit), and white aesthetic covers. Software improvements include head scan image quality enhancement, optional concurrent reconstruction capability, and Size Specific Dose Estimate (SSDE) display.

IEC 60601-1 (General Requirements for Basic Safety), ANSI AAMI IEC 60601-1-2 (Electromagnetic Compatibility), IEC 60601-1-3 (Radiation Protection), IEC 60601-2-44 (Particular Requirements for CT X-ray Equipment), IEC 62366-1 (Usability Engineering), and ISO 10993 (Biocompatibility). Risk management followed ISO 14971, and software lifecycle followed IEC 62304.

The subject device is substantially equivalent because it maintains the identical intended use, target patient population, and core imaging technology as the predicate (K162838) while incorporating only non-functional hardware and software enhancements. Comprehensive verification and validation testing, including regression testing, cybersecurity evaluation, EMC/electrical safety compliance, and phantom-based image quality assessment, confirmed that all modifications do not introduce new risks or adversely affect safety, effectiveness, or the system's fundamental operating principles.