SAO — Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density Class II
FDA product code SAO covers "Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density", a Class II medical device regulated under 21 CFR 892.1171. Submissions are reviewed by the Radiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
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.