BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Akesis Inc.

    Reg #: 3015621321 · FEI: 3015621321 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    4
    Classifications
    2

    Registration Details

    Registration Name
    Akesis Inc.
    Registration Number
    3015621321
    FEI Number
    3015621321
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    5129 Commercial Circle
    City
    Concord
    State
    CA
    ZIP
    94520
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210921

    Owner / Operator

    Firm Name
    Akesis Inc
    Operator Number
    10088577
    Address
    5129 Commercial Circle
    City
    Concord
    State
    CA
    Postal Code
    94520
    Country
    US
    Correspondent
    Lien Pham

    Products

    Device Name Product Code
    System, Radiation Therapy, Radionuclide IWB
    Accelerator, Linear, Medical IYE

    Proprietary Names

    Galaxy RTx Gemini360RT X/Gamma Ray Integrated Digital Radiotherapy System Galaxy RTi Galaxy

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device