SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option

The SpotLight/SpotLight Duo is a computed tomography X-ray system that produces cross-sectional images of the body for cardiovascular and thoracic imaging. The Low Dose Lung Cancer Screening option enables low-dose CT screening for lung cancer detection across all patient size groups (small 50-70 kg, medium 70-90 kg, large 90-120 kg) following established clinical protocols from recognized medical organizations like ACR and AAPM.

No functional, performance, feature, or design changes were made to the CT systems. The device uses identical detector technology (fast scintillator array, 33 or 23 configurable HR modules with 192 detector rows), X-ray sources (2× Varex MCS 2093 tubes), image reconstruction algorithms (modified FDK cone beam), and specifications (250 RPM rotation, 0.24 sec scan time, 140mm axial coverage). The only modification is software activation of LD LCS protocols with CTDI dose values compliant with AAPM requirements for small patients (0.25-2.8 mGy).

Not stated in this summary.

The predicate device (K241200) was cleared with LD LCS protocols for medium and large patients; large/medium patients were designated as worst-case due to increased X-ray attenuation and reduced image quality. Clinical image quality assessment by two U.S. board-certified radiologists evaluated 10 small patient exams at doses <2.8 mGy, all rated diagnostic with detection of small nodules (2mm), matching the performance standard established by K241200. Since small patients present a less challenging imaging scenario than the predicate's worst-case large patients, and bench testing already demonstrated adequate performance across all LD LCS dose ranges, extending the indication to small patients with identical hardware and proven protocols raises no new safety or effectiveness concerns.