Nano-X AI Ltd. radiology AI products

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Radiology AI pricing and total cost of ownership

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FDA-cleared K241440

HealthCCSng

Nano-X AI Ltd.

Authorized purpose: Non-invasive post-processing of routine non-gated, non-contrast CT studies containing the entire heart in adults aged 30 to 85 to evaluate coronary calcified plaque and estimate coronary calcium score and category.

Modality: CT/CTA
Anatomy: Heart and coronary arteries
Decision: 2024-08-19

Cardiac imaging

FDA-cleared K233080

HealthFLD

Nano-X AI Ltd.

Authorized purpose: Provide quantitative and qualitative liver analysis and mean attenuation measurement to support clinician evaluation and assessment of fatty liver in patients aged 18-75 whose CT includes a significant part of the liver; not for diagnosis or risk assessment of fatty liver disease.

Modality: CT/CTA
Anatomy: Liver
Decision: 2024-02-08

Oncology quantification Quantification and segmentation