De Novo · Granted
GrantedRho
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
16 Bit, Inc. · SAO Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
Granted on Apr 9, 2024 as a new device type through De Novo after a 372-day review. 2 later devices descend from it.
- Decided
- Apr 9, 2024
- Review
- 372 days
- Class
- Class II
- Product code
- SAO
- Recalls
- None
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN230023 | Rho | 16 Bit, Inc. | 2024 | — |
| +1 | K253192 | DeepXray Spina | Alpha Intelligence Manifolds, Inc. | 2026 | — |
| +1 | K251408 | OsteoSight™ Hip (v1) | Naitive Technologies, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SAO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new SAO device
- #1 K253192 DeepXray Spinascore 11.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K253192 (Alpha Intelligence Manifolds, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All SAO devicesSAO Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SAO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SAO
Too few SAO 510(k)s in any year since 2007 to give a median.
Recalls per year · SAO
No recall names SAO since 2007.
Adverse event reports per year · SAO
No MAUDE report names SAO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230023 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230023: Rho.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230023
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026