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    FDA UDI In Commercial Distribution 🇺🇸 United States

    CTXA Hip Extended Reference Data

    DI: B052DICTXAHIPEXTDB0 · Model: K030330 · MINDWAYS SOFTWARE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CTXA Hip Extended Reference Data
    Primary DI
    B052DICTXAHIPEXTDB0
    Version / Model
    K030330
    Catalog Number
    DI_CTXAHIPEXTDB
    Company Name
    MINDWAYS SOFTWARE, INC.
    Labeler DUNS
    964202592
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-03-31
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    d9efaa5b-399f-49b5-bcdb-22a78fe98aaf

    Device Description

    The CTXA Hip Extended Reference Data is an accessory to the CTXA Hip Bone Mineral Densitometer. The CTXA Hip Extended Reference Data is used within the CTXA Hip module to calculate T-scores and percent young normal for any patient, and Z-scores for patients age 20-80 for BMD estimates made using the CTXCA Hip module. TThe intended use of the CTXA Hip Extended Reference Data accessory for the CTXA Hip Bone Mineral Densitometry module is to provide a context for the clinical interpretation of a patient's proximal femur BMD estimates. The use of a reference data set and the interpretation of parameters derived by the CTXA Hip module when comparing patient-specific BMD estimates to the installed and selected reference data set is at the discretion of the physician. The predicate K002113 CTXA Hip Bone Mineral Densitometer Module (CTXA Hip) provides estimates of bone mineral content (BMC) and bone mineral density (BMD) values similar to those obtained from DXA devices. These BMD estimates from the predicate device are compared to a reference database of age 20-39 US Caucasian females to calculate T-scores and percent young normal for patient BMD estimates and Z-scores for patient BMD estimates for ages 20-39. The current CTXA Hip Extended Reference Data is an accessory to CTXA Hip that also is used to calculate T-scores and percent young normal, and also is used to calculate Z-scores for ages 20-80. The CTXA Hip BMD estimates referenced to the CTXA Hip Extended Reference Data reference population are used as an aid to the physician in identifying patients with low bone mineral density and as an aid in determining a patient's fracture risk. BMD estimates obtained with CTXA Hip with Extended Reference Data accessory are identical to BMD estimates obtained with the predicate CTXA Hip. T-scores calculated with CTXA Hip with Extended Refecrence Data accessory are slightly less negative or less positive than those calculated with CTXA Hip,approximately 0.1-0.2 T-score units.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KGI Densitometer, Bone

    GMDN Terms

    Code Name
    40867 CT system application software

    Identifiers

    Type ID
    Primary B052DICTXAHIPEXTDB0

    Customer Contacts

    Phone
    +1 512 912-0871
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K030330 000