# K232086: spineEOS

- Pathway: 510(k) (Traditional)
- Applicant: Eos Imaging
- Decided: Oct 24, 2023 after 103 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 11 generations back to K896095 (1990). 24 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160407: spineEOS, Onefit Medical (2016) 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
spineEOS software is indicated for assisting healthcare professionals with preoperative planning of spine surgeries. spineEOS provides access to EOS images with associated 3D datasets and measurements. spineEOS includes surgical planning tools that enable users to define a patient specific surgical strategy.

Source page: https://510kreport.com/device/K232086
Methodology: https://510kreport.com/methodology