BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Rapid ASPECTS

    Reg #: 3011205675 · FEI: 3014269683 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    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
    K232156

    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
    Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer POK

    Proprietary Names

    Rapid ASPECTS

    Establishment Types

    Manufacture Medical Device