BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Focus HD 43 Detector

    Reg #: 1317307 · FEI: 1317307 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Carestream Health, Inc
    Registration Number
    1317307
    FEI Number
    1317307
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1049 West Ridge Road
    City
    Rochester
    State
    NY
    ZIP
    14615
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213529

    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
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    Focus HD 43 Detector

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device