Product code SAO

Device name

Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

Medical specialty

Radiology

Device class

2

Regulation number

892.1171

Review panel

RA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset