BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    isoPoint Validation Software

    DI: B3658080000 · Model: 80-800 · Aktina Corp.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    isoPoint Validation Software
    Primary DI
    B3658080000
    Version / Model
    80-800
    Company Name
    Aktina Corp.
    Labeler DUNS
    787178920
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-07-01
    Public Version
    1
    Public Version Date
    2024-07-09
    Public Version Status
    New
    Public Device Record Key
    fa76726e-261d-4e22-a4b8-8a84eddee62d

    Device Description

    Validation software intended to be used by a Medical Physicist to accept a LINAC for clinical use by performing a Winston-Lutz test.

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LHO Instrument, Quality-Assurance, Radiologic

    GMDN Terms

    Code Name
    38399 Accelerator system quality assurance device

    Identifiers

    Type ID
    Primary B3658080000