FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

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.

FDA #
K250650
Product Code
JAK

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.

FDA #
K241200
Product Code
JAK
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