SAO — Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density Class II
Classification Details
- Product Code
- SAO
- Device Class
- Class II
- Regulation Number
- 892.1171
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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.