# K080529: Stereos Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Biospace Med
- Decided: Aug 29, 2008 after 185 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: 5 generations back to K904519 (1991). 12 ancestors in all.
14 later devices descend from it; 4 cite 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)
- K010938: Syngo Multimodality Workstation, Siemens Medical Solutions USA, Inc. (2001) Summary page 1.
- K071972: Orthopedic Software for Impax Workstations, Agfa Healthcare Corp. (2007) Summary page 1.

## Most influential descendants
- K090050: Stereos Workstation (2010), 13 descendants of its own
- K101398: Stereos Workstation (2011), 12 descendants of its own
- K113344: Stereos Workstation (2012), 11 descendants of its own
- K130395: Stereos Workstation (2013), 10 descendants of its own
- K141137: Stereos Workstation (2014), 9 descendants 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 PACS 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 Biospace EOS System (K071546), 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 16 years and older. The 3D measurement tools include interactive analysis based 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. The model of bone structures is not intended for use in patients with a Cobb's angle > 50 degrees and is not intended for use to assess individual vertebral abnormalities

Source page: https://510kreport.com/device/K080529
Methodology: https://510kreport.com/methodology