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FDA-authorized DEN230023

Rho

16 Bit Inc

Authorized purpose: Rho analyzes standard frontal radiographs opportunistically to identify patients aged 50 years and older who may have low bone mineral density and to prompt clinical bone-health assessment.

Modality
X-ray/Radiography
Anatomy
Lumbar spine, thoracic spine, chest, pelvis, knee, hand, and wrist; low bone-mineral-density screening regions
Decision
2024-04-09