BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    2020 Imaging Podiatry System HF

    DI: 00817100020148 · Model: XR410i · KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    2020 Imaging Podiatry System HF
    Primary DI
    00817100020148
    Version / Model
    XR410i
    Catalog Number
    PXS-710
    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
    b1a0df74-6c0d-490a-88f7-cb645e4180b5

    Device Description

    X-Ray System, Podiatry DR Ready (70kVp,10mA).

    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
    KPR System, X-Ray, Stationary
    MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

    GMDN Terms

    Code Name
    37645 Stationary basic diagnostic x-ray system, digital

    Identifiers

    Type ID
    Primary 00817100020148

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K133959 000