Rho
16 Bit Inc is listed for Rho (DEN230023). The FDA list gives April 9, 2024 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the De Novo pathway. openFDA describes product code SAO as “Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density”: 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. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230023
- Date of final decision
- April 9, 2024
- Company on the FDA list
- 16 Bit Inc
- Lead panel
- Radiology
- Primary product code
- SAO
- openFDA device name for the code
- Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
- Device class
- 2
- Regulation number
- 892.1171
- openFDA decision description
- Unknown
- openFDA decision code
- DENG
- Statement or summary label
- Not returned
Product-code text from openFDA
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.