510(k) DEN230023
DEN230023 is an FDA 510(k) premarket notification submitted by 16 Bit, Inc. for the device "Rho". The FDA issued a decision of De Novo Granted on Apr 9, 2024. The device falls under product code SAO (Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density), a Class II device regulated under 21 CFR 892.1171.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Apr 9, 2024
- Date Received
- Apr 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.