Devices · Alpha Intelligence Manifolds, Inc.

DeepXray Spina

Alpha Intelligence Manifolds, Inc. is listed for DeepXray Spina (K253192). The FDA list gives June 10, 2026 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code SAO as “Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253192

Official FDA database record

Date of final decision

June 10, 2026

Company on the FDA list

Alpha Intelligence Manifolds, Inc.

Lead panel

Radiology

Primary product code

SAO

openFDA device name for the code

Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

Device class

2

Regulation number

892.1171

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary