BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Portable X-Ray System

    DI: 00817100020117 · Model: XR300 · KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Portable X-Ray System
    Primary DI
    00817100020117
    Version / Model
    XR300
    Company Name
    KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
    Labeler DUNS
    080269345
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    885bea6f-a3e3-410b-b149-d3435e4c368f

    Device Description

    SR-130 + DR Portable X-Ray System (100kV/30mA).

    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
    Yes
    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
    IZL System, X-Ray, Mobile

    GMDN Terms

    Code Name
    37643 Portable basic diagnostic x-ray system, digital

    Identifiers

    Type ID
    Primary 00817100020117

    Customer Contacts

    Phone
    1-800-366-5343
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K030494 000