# K101398: Stereos Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Biospace Med
- Decided: Feb 4, 2011 after 262 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K904519 (1991). 14 ancestors in all.
12 later devices descend from it; 2 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)
- K080529: Stereos Workstation, Biospace Med (2008) Summary page 1.
- K090050: Stereos Workstation, Biospace Med (2010) Summary page 1.
- K071972: Orthopedic Software for Impax Workstations, Agfa Healthcare Corp. (2007) Summary page 1.

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

## Recalls of this device
- Apr 13, 2011 · Not classified · Z-2692-2011: Print true size, print requests from the EOS acquisition station or the sterEOS image review station may, in certain cases, be affected by a different enlargement factor during printing. T

## 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 20 X-ray images of the musculoskeletal system including interactive 20 measurement tools. When using 20 X-ray images obtained with the EQS Imaging EQS 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 7 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. -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 20/3D ruler is indicated for measurements in patient younger than 15 years old.

Source page: https://510kreport.com/device/K101398
Methodology: https://510kreport.com/methodology