Device type

Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

Product code SAO · Class II · 21 CFR 892.1171 · Radiology

This device is software which opportunistically assesses radiological images to estimate bone mineral density (BMD) intended to assist in a healthcare professional's decision to evaluate patients for possible low BMD within a bone health screening program. The software employs an algorithm that estimates BMD using eligible radiological image data obtained for other clinical purposes.

FDA classification database