BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CMR NAVISCAN CORPORATION

    Reg #: 3005945241 · FEI: 3005945241 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    CMR NAVISCAN CORPORATION
    Registration Number
    3005945241
    FEI Number
    3005945241
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2720 Loker Ave W Ste O
    City
    Carlsbad
    State
    CA
    ZIP
    92010
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111731

    Owner / Operator

    Firm Name
    CMR Naviscan Corporation
    Operator Number
    10045732
    Address
    2720 Loker Ave W Ste O
    City
    Carlsbad
    State
    CA
    Postal Code
    92010
    Country
    US
    Correspondent
    Larry Lugo

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    System, Tomography, Computed, Emission KPS
    Camera, Scintillation (Gamma) IYX

    Proprietary Names

    LumaGEM MBI Software LumaGEM Scintillation Camera LumaGEM Molecular Breast Imaging (MBI) System

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198