BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SPY-PHI Pack with SPY AGENT GREEN

    Reg #: 3015532525 · FEI: 3015532525 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CARESTREAM HEALTH, INC.
    Registration Number
    3015532525
    FEI Number
    3015532525
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    882 Linden Ave.
    City
    Rochester
    State
    NY
    ZIP
    14625
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192174

    Owner / Operator

    Firm Name
    Carestream Health, Inc.
    Operator Number
    9097221
    Address
    150 Verona Street
    City
    Rochester
    State
    NY
    Postal Code
    14608
    Country
    US
    Correspondent
    Alyssa J Haig

    Products

    Device Name Product Code
    Confocal Optical Imaging OWN
    System, X-Ray, Angiographic IZI

    Proprietary Names

    SPY-PHI Pack with SPY AGENT GREEN SPY-PHI Kit with SPY AGENT GREEN

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)