BEUDAMED
    FDA Registration Active 🇨🇳 China

    CARESTREAM HEALTH, INC., GLOBAL R&D CENTER

    Reg #: 3005778458 · FEI: 3005778458 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    CARESTREAM HEALTH, INC., GLOBAL R&D CENTER
    Registration Number
    3005778458
    FEI Number
    3005778458
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Bldg 15, No. 27 Xin Jinqiao Road
    City
    SHANGHAI
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K100094

    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

    US Agent

    Business Name
    CARESTREAM HEALTH, INC.
    Contact Name
    Alyssa Haig
    Address
    150 Verona St
    City
    ROCHESTER
    State
    NY
    ZIP
    14608
    Country
    US
    Email
    [email protected]
    Phone
    610 8066895

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Table, Radiographic, Non-Tilting, Powered IZZ
    System, X-Ray, Stationary KPR
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    Table, Radiologic KXJ
    Tube Mount, X-Ray, Diagnostic IYB
    Generator, High-Voltage, X-Ray, Diagnostic IZO
    Holder, Radiographic Cassette, Wall-Mounted IXY

    Proprietary Names

    Carestream Image Suite QT-740 QT-750 DRX-Ascend System Focus 35C Detector TRIMAX 35C Detector SPT2 RADIOGRAPHIC TABLE CARESTREAM DR LONG LENGTH IMAGING STAND Lux HD 43 Detector CARESTREAM DRX-EVOLUTION PLUS DRX-Compass X-ray System Lux HD 35 Detector DR-FIT X-ray System QS-500 X-RAY GENERATOR SYSTEM (REF: QG-50-2, QG-50, QG-50-SE, QG-65, QG-80) X-RAY GENERATOR SYSTEM (REF: QG-40, QG-40-2, QG-40-3, QG-40-SE) QW-420 QR-LCH,QT-LCH,QT-LCH-P,QT-TCH

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility