BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    MR-RT

    DI: 00884838103528 · Model: RT CouchTop XD · Philips Oy
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MR-RT
    Primary DI
    00884838103528
    Version / Model
    RT CouchTop XD
    Catalog Number
    781439
    Company Name
    Philips Oy
    Labeler DUNS
    539852079
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-08-31
    Public Version
    2
    Public Version Date
    2023-01-23
    Public Version Status
    Update
    Public Device Record Key
    c31a57b2-0c2f-4489-adab-b6ecf1e2961c
    Distribution End Date
    2022-10-01

    Device Description

    MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes.

    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
    LNH System, Nuclear Magnetic Resonance Imaging

    GMDN Terms

    Code Name
    61110 Radiation therapy treatment planning positioning kit

    Identifiers

    Type ID
    Primary 00884838103528

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    20 – 95 Percent (%) Relative Humidity