DeepXray Spina is an AI-enabled medical device from Alpha Intelligence Manifolds, Inc. that the U.S. FDA cleared through 510(k) K253192 on June 10, 2026. Its lead review panel is Radiology and its primary product code is SAO (Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density).
See also FDA-cleared AI radiology devices in 2026, all FDA AI clearances in 2026, top radiology AI devices.
Key facts
| Submission number | K253192 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Alpha Intelligence Manifolds, Inc. |
| Lead review panel | Radiology |
| Primary product code | SAO — Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density |
| Applicant (openFDA) | Alpha Intelligence Manifolds, Inc. |
| Applicant location | New Taipei City, TW |
| Device class | Class 2 |
| Regulation number | 21 CFR 892.1171 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. DeepXray Spina went through this pathway (K253192).
openFDA lists it as a Class 2 device under 21 CFR 892.1171. Class II devices are moderate risk and are subject to general and special controls.
Product code SAO covers 3 devices on the FDA AI list. By decision date, this device is #3 of 3 under that code. Alpha Intelligence Manifolds, Inc. has 2 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.