SAO

Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

Product code

SAO

Device name

Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

Device class

Class 2

21 CFR

21 CFR 892.1171

Medical specialty

Radiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

3

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-06-10.

2 summaries are archived here for direct download.