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 computed tomography (CT) X-ray system developed by Arineta Ltd. It produces detailed cross-sectional images of the body, especially of the cardiovascular and thoracic areas, enabling clinicians to screen and diagnose lung cancer using low-dose CT protocols. This device helps physicians detect lung nodules and other thoracic abnormalities with reduced radiation exposure, supporting effective lung cancer screening programs following clinical guidelines.
Intended Use
The SpotLight Computed Tomography X-ray system is intended for head, body, cardiac and vascular X-ray computed tomography applications. The Low Dose CT Lung Cancer Screening Option is indicated for using low dose CT for lung cancer screening following established program criteria and protocols.
Technology
The device uses fast scintillator array detector technology, dual X-ray tubes, modified FDK cone beam reconstruction algorithms adapted for dual tubes geometry, and includes adaptive filters for noise reduction. The Low Dose Lung Cancer Screening option introduces specific low-dose scan protocols compliant with AAPM guidelines without requiring hardware changes. The device does not support DLIR or ASIR-CV algorithms under the low dose screening option.
Performance
Extensive bench testing demonstrated that image quality metrics such as CT number accuracy and uniformity, noise power spectrum, resolution, contrast to noise ratio, and nodule detectability were substantially equivalent to predicate devices. Clinical testing by board-certified radiologists confirmed diagnostic image quality for medium and large patient sizes relevant for lung cancer screening without raising safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/30/2024
8 months - 2
FDA Approval
1/13/2025
Other devices from Arineta Ltd.
- SpotLight/SpotLight Duo (with DLIR option)2023 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.