uCT 550

The uCT 550 is a computed tomography X-ray system that produces cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. It is indicated for whole-body imaging including head, neck, cardiac, and vascular applications.

The device has a 70 cm bore gantry with 0.5s rotation speed, 22 mm solid-state GOS detector with 40 rows and 864 channels per row, X-ray tube operating at 70–140 kV with 10–420 mA range, 50 kW high voltage generator, and 205 kg patient table capacity. It generates 80 slices per rotation with reconstruction field of view of 40–700 mm with extended FOV. Application features include DELTA (AI-based deep learning noise reduction), Auto ALARA, Motion Freeze, EasyRange, and CT-guided intervention.

Conformance claimed to IEC 61223-3-5 for general IQ performance testing, IEC 60601-1 series for medical electrical equipment safety and EMC, IEC 60601-2-44 for CT equipment, NEMA XR 25/28/29 for CT dose management, ISO 10993 series for biocompatibility, and ISO 14971 for risk management.

The proposed device shares identical core hardware specifications (gantry rotation, detector configuration, X-ray tube parameters, power, patient table capacity) with the predicate device K200016. The primary differences are enhanced software features—DELTA with expanded noise reduction levels, Motion Freeze for head motion correction, and optimized EasyRange—which improve image quality and workflow without altering the fundamental intended use or creating new safety concerns. Bench testing demonstrates DELTA achieves better low-contrast detectability and noise reduction compared to FBP at equivalent or reduced dose, and clinical evaluation confirmed diagnostic image quality. These software enhancements do not change the device's fundamental operating principles, safety profile, or clinical applicability.