# K253192: DeepXray Spina

- Pathway: 510(k) (Traditional)
- Applicant: Alpha Intelligence Manifolds, Inc.
- Decided: Jun 10, 2026 after 257 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
Longest line of descent: 1 generation back to DEN230023 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230023: Rho, 16 Bit, Inc. (2024) Summary page 5.

## Indications for use
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).

Source page: https://510kreport.com/device/K253192
Methodology: https://510kreport.com/methodology