BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Standard Imaging Adaptivo

    DI: 00866562000243 · Model: v1 · STANDARD IMAGING INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Standard Imaging Adaptivo
    Primary DI
    00866562000243
    Version / Model
    v1
    Catalog Number
    91350
    Company Name
    STANDARD IMAGING INC.
    Labeler DUNS
    788084705
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-11
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    b910bf27-b723-40ed-b1d2-19f7f541b8fd

    Device Description

    Standard Imaging Adaptivo Software is a stand alone software medical device used for QA checks of comparative and cumulative dose received during radiation treatment from radiation therapy systems.

    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
    IYE Accelerator, Linear, Medical

    GMDN Terms

    Code Name
    40887 Radiation therapy software

    Identifiers

    Type ID
    Primary 00866562000243