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FDA-cleared K213944

HealthOST

NanoxAI Ltd.

Authorized purpose: Qualitative and quantitative spine analysis from CT images to support clinician evaluation of musculoskeletal spinal disease, including vertebral labeling, vertebral height-loss measurement, and mean vertebral Hounsfield-unit measurement in patients aged 50 and over.

Modality
CT/CTA
Anatomy
Spine, including T1-L4 vertebrae and T11-L4 trabecular bone regions
Decision
2022-04-22