BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    QCT BONE MINERAL ANALYSIS SOFTWARE

    K Number: K992246 · Decision Sep 3, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    146
    Applicant Total
    9
    Review Days
    59

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    Basic Information

    Device Name
    QCT BONE MINERAL ANALYSIS SOFTWARE
    K Number
    K992246
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1170
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Image Analysis, Inc.
    Date Received
    July 6, 1999
    Decision Date
    September 3, 1999
    Product Code
    KGI
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KGI Densitometer, Bone

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    Other Clearances by Image Analysis, Inc.

    K Number Device Name
    K040782 N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX
    K031991 DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS
    K952060 QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000
    K941127 QCT-BONE MINERAL ANALYSIS SOFTWARE
    K941126 QCT-BONE MINERAL ANALYSIS PHANTOM
    K891931 QCT-LUNG NODULE (TM) ANALYSIS PACKAGE
    K852509 QCT-BONE MINERAL PHANTOM
    K852510 COMPUTED TOMOGRAPHY COUCH PAD FOR MIN ANALYSIS