SpotLight/SpotLight Duo (with DLIR option)
Arineta Ltd.SpotLight/SpotLight Duo (with DLIR option) is a CT scanner that produces cross-sectional images of the body, including cardiovascular and thoracic anatomies. It uses a dual-tube CT system and advanced deep learning reconstruction to enhance image quality while reducing noise. This helps clinicians obtain clearer diagnostic images for disease detection and therapy planning.
Intended Use
Intended for head, body, cardiac and vascular X-ray Computed Tomography applications producing cross-sectional images useful for diagnosis and therapy planning.
Technology
Multislice dual-tube CT scanner with 192 detector rows, using a fast scintillator array, direct drive DC motor gantry rotation, and integrated Deep Learning Image Reconstruction (DLIR) software as an alternative image noise reduction method replacing ASIR-CV.
Performance
The device was tested according to relevant IEC standards, verified with phantoms and clinical data demonstrating DLIR achieves equivalent or improved noise reduction and image quality compared to ASIR-CV, without compromising spatial resolution or accuracy. Clinical blinded reader studies confirmed diagnostic image quality is not inferior to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/10/2023
8 months - 2
FDA Approval
10/13/2023
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