BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Nanox.ARC

    Reg #: 3022810909 · FEI: 3022810909 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Dagesh F.K. Ltd.
    Registration Number
    3022810909
    FEI Number
    3022810909
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6 Ovaia street
    City
    Yad Binyamin Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K242395

    Owner / Operator

    Firm Name
    Nano-X Imaging Ltd
    Operator Number
    10088182
    Address
    94 Em Hamoshavot Road, Brosh building Ofer Tech Park PO Box 3486
    City
    PETAH TIKVA
    State
    Central
    Postal Code
    4910402
    Country
    IL
    Correspondent
    Noa First

    US Agent

    Business Name
    Nanox Imaging Inc.
    Contact Name
    Ran Daniel
    Address
    400 Kelby St, Suite 702
    City
    Fort Lee
    State
    NJ
    ZIP
    07024
    Country
    US
    Email
    [email protected]
    Phone
    212 9820269

    Products

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

    Proprietary Names

    Nanox.ARC

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)