# K231917: VEA Align

- Pathway: 510(k) (Traditional)
- Applicant: Eos Imaging
- Decided: Jan 5, 2024 after 190 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K904519 (1991). 20 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172346: sterEOS Workstation, Eos Imaging (2018) Summary page 4.

## Most influential descendants
- K240582: VEA Align; spineEOS (2024), 4 descendants of its own
- K252103: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (2025), 1 descendant of its own
- K251747: VEA Align; spineEOS (2025), 1 descendant of its own
- K260322: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (2026), 0 descendants of its own
- K251078: AutoDensity (2025), 0 descendants of its own

## Indications for use
This cloud-based software is intended for orthopedic applications in both pediatric and adult populations. 2D X-ray images acquired in EOS imaging’s imaging systems is the foundation and resource to display the interactive landmarks overlayed on the frontal and lateral images. These landmarks are available for users to assess patient-specific global alignment. For additional assessment, alignment parameters compared to published normative values may be available. This product serves as a tool to aid in the analysis of spinal deformities, degenerative diseases, lower limb alignment disorders, and deformities through precise angle and length measurements. It is suitable for use with adult and pediatric patients aged 7 years and older. Clinical judgment and experience are required to properly use the software.

Source page: https://510kreport.com/device/K231917
Methodology: https://510kreport.com/methodology