Radiology · 510(k) · 2026
DeepXray Spina
Alpha Intelligence Manifolds, Inc.. Cleared by FDA on 10 June 2026 under submission K253192, product code SAO (radiology software for opportunistic evaluation of low bone mineral density). What FDA's record says, in FDA's words.
Device record · K253192
- Device. DeepXray SpinaDEVICE
- Company. Alpha Intelligence Manifolds, Inc. (TW)COMPANY
- Decision. 10 June 2026, 510(k), substantially equivalent (traditional review); received 26 September 2025DECISION
- Panel. RadiologyPANEL
- Product code. SAO, Radiology Software For Opportunistic Evaluation Of Low Bone Mineral DensityCODE
- Regulation. 21 CFR 892.1171, Class IIREG
- Source. FDA database entry · decision document (17 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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).
The product code's definition, from FDA's classification record. This device is software which opportunistically assesses radiological images to estimate bone mineral density (BMD) intended to assist in a healthcare professional's decision to evaluate patients for possible low BMD within a bone health screening program. The software employs an algorithm that estimates BMD using eligible radiological image data obtained for other clinical purposes.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedradiographs (X-ray)
- Mentionsan adjunct to the clinician, not a replacement
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SAO. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SAO, in Radiology, from Alpha Intelligence Manifolds, Inc., or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.