# DEN230023: Rho

- Pathway: De Novo (Direct)
- Applicant: 16 Bit, Inc.
- Decided: Apr 9, 2024 after 372 days
- Product code: SAO (Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density)
- Device class: 2
- Regulation: 21 CFR 892.1171
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K253192: DeepXray Spina (2026), 0 descendants of its own
- K251408: OsteoSight™ Hip (v1) (2025), 0 descendants of its own

## Indications for use
Rho is a software application intended for use opportunistically with standard frontal radiographs of the lumbar spine, thoracic spine, chest, pelvis, knee, or hand/wrist performed in patients aged 50 years and older. Rho provides a notification in the form of a report to aid radiologists and/or physician interpreters in identifying patients with possible low bone mineral density (BMD) at L1-L4 or the femoral neck to prompt a clinical assessment of bone health. Rho should not be used to rule out low BMD. Radiologists and referring clinicians should follow recommended practices for screening and assessment, regardless of the absence of Rho report.

Source page: https://510kreport.com/device/DEN230023
Methodology: https://510kreport.com/methodology