The Horizon® Dual-Energy X-Ray Absorptiometry (DXA) System is a computer-assisted X-Ray scanner used to aid a physician in measuring bone mineral density (BMD), determining fracture risk, and estimating the lean body mass and fat mass of non-osseous tissues.


Product Overview

The Horizon® Dual
Horizon W - Horizon W


Device Description

An assembly of devices designed for bone density measurements and other calculations based on data obtained using a two distinct photon energy peak. Also referred to as a bone densitometer. It utilizes an x-ray tube or tubes as the photon source which are mechanically aligned and moves along with a photon detector assembly typically in a rectilinear pattern. The collimated beam is directed through an anatomical region of interest and the differential absorption patterns are detected. This information is used in calculations to estimate bone mineral density (osteoporosis), subcutaneous fat, fracture risk.


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 10.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: KGI

    Device Name: Densitometer, Bone

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: RA

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 892.1170

    Third Party Flag: Y

    Medical Specialty: RA


    Device Identifiers

    Device Id: 15420045505834

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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