LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K983724
    Device Name
    ORCA-DX BONE DENSITOMETER
    Manufacturer
    LUNAR CORP.
    Date Cleared
    1998-12-08

    (47 days)

    Product Code
    KGI
    Regulation Number
    892.1170
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    k970224
    Why did this record match?
    Device Name :

    ORCA-DX BONE DENSITOMETER

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

    The ORCA-DX® Bone Densitometer provides an estimate of BMD for the heel and forearm.
    The ORCA-DX® Bone Densitometer requires a 4-second exposure for BMD with a skin entrance dose of

    Device Description

    The ORCA-DX Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2) for the heel and forearm, using dual-energy x-ray absorptiometry.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the LUNAR ORCA-DX Bone Densitometer, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criterion (Implicit)Reported Device Performance
    Safety: Total exposure dose (lower than predicate and safe)**Radiation exposure is
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1