Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K160914
    Device Name
    sterEOS Workstation
    Manufacturer
    EOS IMAGING, INC.
    Date Cleared
    2016-04-22

    (21 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    EOS IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopediativ 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. The 3D measurement tools 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, 47 patients with moderate idiopathic scoliosis and 37 patients with 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 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.
    Device Description
    The sterEOS Workstation is a general system for acceptance, transfer, display, storage, and digital processing of 2D X-ray images of the musculoskeletal system, including interactive 2D measurement tools. When used with 2D X-ray images obtained with the EOS imaging's EOS System (K152788), the sterEOS Workstation provides interactive 3D measurement tools to aid in the analysis of skeletal deformities in spine and lower limbs.
    Ask a Question

    Page 1 of 1