BEUDAMED
    FDA Registration Active 🇺🇸 United States

    iSchemaView Lumina 3D

    Reg #: 3011205675 · FEI: 3014269683 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ISCHEMAVIEW, INC.
    Registration Number
    3011205675
    FEI Number
    3014269683
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1120 Washington Ave, Ste 200, #108
    City
    Golden
    State
    CO
    ZIP
    80401
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243350

    Owner / Operator

    Firm Name
    iSchemaView, Inc.
    Operator Number
    10047732
    Address
    1120 Washington Ave, Suite 200, Rm 108
    City
    Golden
    State
    CO
    Postal Code
    80401
    Country
    US
    Correspondent
    James R Rosa

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    iSchemaView Lumina 3D Lumina 3D Lumina 3D by RapidAI Rapid N3D Rapid Neuro 3D Lumina 3D by iSchemaView

    Establishment Types

    Manufacture Medical Device