SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
Arineta Ltd.The SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option is a CT X-ray system that produces cross-sectional images of the body, particularly the cardiovascular and thoracic regions. It includes protocols for low dose CT scans aimed at lung cancer screening, ensuring minimal radiation exposure while maintaining image quality. This device assists clinicians in diagnosing lung cancer and planning related therapies, utilizing advanced image reconstruction algorithms and adaptable scan techniques for patients of various sizes.
Intended Use
The SpotLight Computed Tomography X-ray system is intended for head, body, cardiac and vascular X-ray computed tomography applications, with a low dose CT option indicated for lung cancer screening.
Technology
The device uses dual X-ray tubes with fast scintillator arrays and photodiode arrays, multi-core PC and GPU for image reconstruction, employing a modified FDK cone beam algorithm with adaptive filters to reduce noise. It supports multiple detector configurations and scan modes including axial, cine, and cardiac, optimized for dose and image quality.
Performance
Clinical testing included evaluations by board-certified radiologists of low dose lung screening exams on small, medium, and large patient cohorts, showing diagnostic image quality and detection of small nodules at low radiation doses. Bench testing supported adequate performance across all protocols with no new safety concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/4/2025
1 month - 2
FDA Approval
4/15/2025
Other devices from Arineta Ltd.
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