510(k) · Cleared
ClearedDeepXray Spina
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alpha Intelligence Manifolds, Inc. · SAO Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
Cleared on Jun 10, 2026 as substantially equivalent to DEN230023 (16 Bit, Inc., 2024) after a 257-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Jun 10, 2026
- Review
- 257 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 deviceK253192 DeepXray SpinaAlpha Intelligence Manifolds, Inc. · 2026
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) | K253192 | DeepXray Spina | Alpha Intelligence Manifolds, Inc. | 2026 | — |
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 K251408 OsteoSight™ Hip (v1)score 9.9 · 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…mineral density Device Class: Class II Review Panel: Radiology Predicate Devices: 16 Bit Rho (DEN230023) Device Description DeepXray Spina is a software-only medical device (SaMD) that identifies patients with Low BMD (T-score ≤ –… | 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. 2026, 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?
DeepXray Spina is a software application intended for use opportunistically with standard frontal radiographs of the lumbar spine or KUB (kidney, ureter, and bladder) performed in patients aged 50 years and older. DeepXray Spina 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 to prompt a clinical assessment of bone health.…
Read the full statement (202 words)
DeepXray Spina is a software application intended for use opportunistically with standard frontal radiographs of the lumbar spine or KUB (kidney, ureter, and bladder) performed in patients aged 50 years and older. DeepXray Spina 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 to prompt a clinical assessment of bone health. DeepXray Spina 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 a DeepXray Spina report.
Input Restriction: DeepXray Spina is intended for use with standard frontal radiographs of the lumbar spine or KUB that are suitable for L1–L4 BMD analysis. The device is not intended for use with images in which one or more L1–L4 vertebrae contains: (a) metallic spinal implants or prostheses (e.g., pedicle screws, rods, cages, or total disc replacements); (b) vertebral cement augmentation (e.g., kyphoplasty or vertebroplasty); (c) severe vertebral deformity, fracture, or other structural abnormality that would preclude a valid DXA-based L1–L4 BMD measurement; or (d) extraspinal medical implants overlying the L1–L4 measurement region (e.g., abdominal aortic stent grafts or vascular grafts).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253192: DeepXray Spina.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253192
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026