BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ImagingRing m

    DI: 19120075320068 · Model: 1 · medPhoton GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ImagingRing m
    Primary DI
    19120075320068
    Version / Model
    1
    Company Name
    medPhoton GmbH
    Labeler DUNS
    300376801
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-22
    Public Version
    3
    Public Version Date
    2022-02-21
    Public Version Status
    Update
    Public Device Record Key
    fd889ba5-27e0-4697-963a-fba7115aa248

    Device Description

    Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluoroscopic devices intended to acquire, display and process both: 1) two- and/or three-dimensional (3-D) cross-sectional (tomographic) images; and 2) real-time fluoroscopic images, from any part of the body for a variety of applications.

    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
    MR Unsafe
    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
    OWB Interventional Fluoroscopic X-Ray System

    GMDN Terms

    Code Name
    65365 Multi-modality diagnostic x-ray system, mobile

    Identifiers

    Type ID
    Primary 19120075320068

    Premarket Submissions

    Submission Number Supplement Number
    K203281 000