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510(k) Data Aggregation

    K Number
    K982267
    Device Name
    DPX-RX BONE DENSITOMETER
    Manufacturer
    LUNAR CORP.
    Date Cleared
    1998-08-18

    (50 days)

    Product Code
    KGI
    Regulation Number
    892.1170
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K904980,K945526
    Why did this record match?
    Device Name :

    DPX-RX BONE DENSITOMETER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DPX-RX Bone Densitometer provides an estimate of BMD at the lumbar Spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician. The use of the DPX-RX Bone Densitometer is restricted to prescription use only.

    Device Description

    The DPX-RX Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2) of the lumbar spine and the proximal femur.

    AI/ML Overview
    1. Table of Acceptance Criteria and Reported Device Performance:
    Acceptance CriteriaReported Device Performance
    Correlation with DPX-Lr > 0.98
    Average BMD ValuesVery similar to DPX-L in 50 subjects in vivo
    Average Short-Term Precision (%CV) In Vitro
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