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FDA-cleared K251408

OsteoSight™ Hip (v1)

Naitive Technologies Ltd

Authorized purpose: Opportunistically analyzes standard AP hip or pelvis radiographs in patients aged 50 years and older and issues a report when the estimated femoral-neck BMD is below a preset threshold to prompt clinical bone-health assessment; absence of a report does not rule out low BMD.

Modality
X-ray/Radiography
Anatomy
MSK
Decision
2025-09-02