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FDA-cleared K250650

SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option

Arineta Ltd.

Authorized purpose: SpotLight and Duo produce cross-sectional images from X-ray transmission data for cardiovascular and thoracic examinations, including heart imaging with or without contrast and a low-dose lung-cancer-screening option used under established governmental or professional protocols.

Modality
CT/CTA
Anatomy
Cardiovascular, thoracic, and lung anatomy
Decision
2025-04-15
FDA-cleared K241200

SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option

Arineta Ltd.

Authorized purpose: SpotLight and Duo produce cross-sectional images from X-ray transmission data for cardiovascular and thoracic examinations, including heart imaging with or without contrast and low-dose lung-cancer-screening protocols under established governmental or professional guidance.

Modality
CT/CTA
Anatomy
Cardiovascular, thoracic, and lung anatomy
Decision
2025-01-13
FDA-cleared K230370

SpotLight/SpotLight Duo (with DLIR option)

Arineta Ltd.

SpotLight and SpotLight Duo are dedicated cardiovascular and thoracic CT systems; K230370 adds optional deep-learning image reconstruction for patients older than 2 years to reduce image noise while maintaining CT number accuracy, high-contrast resolution, and diagnostic image quality.

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2023-10-13