BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INVISION MEDICAL TECHNOLOGY

    Reg #: 3042902406 · FEI: 3042902406 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    INVISION MEDICAL TECHNOLOGY
    Registration Number
    3042902406
    FEI Number
    3042902406
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1497 Samedra St
    City
    Sunnyvale
    State
    CA
    ZIP
    94087
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243866

    Owner / Operator

    Firm Name
    InVision Medical Technology
    Operator Number
    10094692
    Address
    1497 Samedra Street
    City
    Sunnyvale
    State
    CA
    Postal Code
    94087
    Country
    US
    Correspondent
    David Ouyang

    Products

    Device Name Product Code
    Adjunctive Cardiac Amyloidosis Status Indicator SDJ
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    Precision Cardiac Amyloid Precision LVEF

    Establishment Types

    Manufacture Medical Device