510(k) DEN230023
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 9, 2024
- Date Received
- April 3, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
- Device Class
- Class II
- Regulation Number
- 892.1171
- Review Panel
- RA
- Submission Type
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.