Arineta Ltd. radiology AI products

FDA-cleared K250650

SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option

Arineta Ltd.

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...

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

Cardiac imaging

FDA-cleared K241200

SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option

Arineta Ltd.

SpotLight and SpotLight Duo produce cross-sectional cardiovascular and thoracic CT images, with the Low Dose Lung Cancer Screening Option for the labeled screening workflow, for...

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

CT/CTA workflow

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...

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

Cardiac imaging