510(k) · Cleared
ClearedOsteoSight™ Hip (v1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Naitive Technologies, Ltd. · SAO Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
Cleared on Sep 2, 2025 as substantially equivalent to DEN230023 (16 Bit, Inc., 2024) after a 119-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Sep 2, 2025
- Review
- 119 days
- Class
- Class II
- Product code
- SAO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230023 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230023 Rho16 Bit, Inc. · 2024
- This deviceK251408 OsteoSight™ Hip (v1)Naitive Technologies, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230023 | Rho | 16 Bit, Inc. | 2024 | — |
| 0 (this device) | K251408 | OsteoSight™ Hip (v1) | Naitive Technologies, Ltd. | 2025 | — |
Sources: FDA 510(k) 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN230023 | RhoSummary page 5…ice: OsteoSight™ Hip (v1) Classification: Class II Product Code: SAO Regulation: 21 CFR 892.1171 Predicate Device Manufacturer: 16 Bit Inc Device: Rho Predicate Number: DEN230023 Indications for Use OsteoSight™ is a software application intended for use opportunistically with standard anteroposterior (AP)… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN230023.
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. 2025, 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?
OsteoSight™ is a software application intended for use opportunistically with standard anteroposterior (AP) radiographs of the hip or pelvis performed in patients aged 50 years and older. OsteoSight™ 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 the femoral neck to prompt a clinical assessment of bone health. OsteoSight™ 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 an OsteoSight™ report.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251408 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251408: OsteoSight™ Hip (v1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251408
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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