# K141137: Stereos Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Eos Imaging
- Decided: Sep 15, 2014 after 137 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: 10 generations back to K904519 (1991). 17 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130395: Stereos Workstation, Eos Imaging, Inc. (2013) Summary page 5.

## Most influential descendants
- K160914: sterEOS Workstation (2016), 8 descendants of its own
- K172346: sterEOS Workstation (2018), 7 descendants of its own
- K231917: VEA Align (2024), 5 descendants of its own
- 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

## Indications for use
The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopedics in both pediatric and adult populations as a general device for acceptance, transfer, display, storage, and digital processing of 2D X-ray images of the musculoskeletal system including interactive 2D measurement tools. When using 2D X-ray images obtained with the EOS Imaging EOS System, the sterEOS Workstation provides interactive 3D measurement tools: To aid in the analysis of scoliosis and related disorders and deformities of the spine in adult patients as well as pediatric patients. The 3D measurement tools include interactive analysis based either on identification of anatomical landmarks for postural assessment or on a model of bone structures derived from an a priori image data set from 175 patients (91 normal patients, 47 patients with moderate idiopathic scoliosis and 37 patients with severe idiopathic scoliosis), and dry isolated vertebrae data for spine modeling. The model of bone structures is not intended for use to assess individual vertebral abnormalities and is indicated only for patients 7 years and older. For postural assessment, a set of comparative tools is provided allowing the comparison of performed measurements to reference values for patients over 18 years old. To aid in the analysis of lower limbs alignment and related disorders and deformities based on angle and length measurements. The 3D measurement tools include interactive analysis based either on identification of lower limb alignment landmarks or as for the spine, on a model of bone structures derived from an a priori image data set. The model of bone structures is not intended for use to assess individual bone abnormalities. The 3D package including model-based measurements and torsion angles is indicated only for patients 15 years or older. Only the 2D/3D ruler is indicated for measurements in patients younger than 15 years old.

Source page: https://510kreport.com/device/K141137
Methodology: https://510kreport.com/methodology