BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    X-ray Flat Panel Detectors/CareView 3600RF

    K Number: K202995 · Decision Feb 19, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    10
    Review Days
    141

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    Basic Information

    Device Name
    X-ray Flat Panel Detectors/CareView 3600RF
    K Number
    K202995
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Careray Digital Medical System Co., Ltd.
    Date Received
    October 1, 2020
    Decision Date
    February 19, 2021
    Product Code
    MQB
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

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    Other Clearances by Careray Digital Medical System Co., Ltd.

    K Number Device Name
    K201932 X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)
    K193173 CareView 1800Le
    K172581 CareView 1800Cw X-ray Flat Panel Detectors
    K163019 CareView 750Cw/750C X-ray Flat Panel Detectors
    K162178 CareView 1500P X-ray Flat Panel Detectors
    K153492 CareView 1800L
    K153058 CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors
    K141488 CAREVIEW 1800R
    K150929 CareView 1500Cw X-ray Flat Panel Detectors