uCT 780

The uCT 780 is a computed tomography X-ray system that produces cross-sectional images of the body for diagnostic purposes, including whole-body imaging (head, neck, cardiac, vascular). It is also intended for low-dose CT lung cancer screening to detect lung nodules that may represent cancer, performed within established clinical protocols. The device includes uWS-CT-Dual Energy Analysis software for post-processing images acquired at different tube voltages to characterize material composition.

The primary change is modification of the DELTA (Deep Recon) AI-based deep learning reconstruction algorithm. The proposed device increases user interface noise reduction levels from 4 to 5 levels and expands the training dataset from an original size to 127 cases to improve algorithm robustness. Hardware environment and software platform remain identical to the predicate; applicable body parts, clinical workflow, and indications for use are unchanged.

IEC 61223-3-5 (general CT image quality performance metrics including HU number and thickness section testing); MITA CCT189 and MITA CCT191 phantoms for low contrast detectability testing; Catphan 700 and water phantoms for baseline image quality assessment.

The device is substantially equivalent because the DELTA algorithm modifications do not change the intended use, scientific technology, or clinical workflow compared to the predicate K230162. Bench testing demonstrated DELTA produces equivalent or better image quality compared to FBP reconstruction with improved noise, contrast detectability, and spatial resolution at equivalent doses, or equivalent image quality at reduced doses. Clinical evaluation by board-certified radiologists on 60 subjects (20 validation, 40 test cases) across head, chest, abdomen, and cardiac protocols confirmed acceptance criteria were met. The dataset expansion and additional noise reduction level represent incremental algorithm optimization that does not introduce new safety or effectiveness concerns.