FDA-cleared K241440

HealthCCSng

Nano-X AI Ltd.

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...

Modality
CT/CTA
Anatomy
Heart and coronary arteries
Decision
2024-08-19
FDA-cleared K233080

HealthFLD

Nano-X AI Ltd.

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...

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