BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Nanox.ARC X

    DI: 07290018465011 · Model: Nanox.ARC X · NANO-X IMAGING LTD
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Nanox.ARC X
    Primary DI
    07290018465011
    Version / Model
    Nanox.ARC X
    Company Name
    NANO-X IMAGING LTD
    Labeler DUNS
    521092973
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-09-04
    Public Version
    2
    Public Version Date
    2025-12-01
    Public Version Status
    Update
    Public Device Record Key
    c43386c1-b869-4d8b-8270-44efcdffe0ba

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IZF System, X-Ray, Tomographic
    MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

    GMDN Terms

    Code Name
    37660 Multi-directional tomography x-ray system

    Identifiers

    Type ID
    Primary 07290018465011