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    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Philips CombiDiagnost R90

    K Number: K163210 · Decision Jan 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    299
    Applicant Total
    18
    Review Days
    77

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    Basic Information

    Device Name
    Philips CombiDiagnost R90
    K Number
    K163210
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems Dmc GmbH
    Date Received
    November 15, 2016
    Decision Date
    January 31, 2017
    Product Code
    JAA
    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

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    Other Clearances by Philips Medical Systems Dmc GmbH

    K Number Device Name
    K233662 Radiography 7300 C
    K233678 Radiography 7000 M
    K233945 ProxiDiagnost N90 / Precision CRF (706110, 706400)
    K232910 CombiDiagnost R90
    K212186 Philips Radiology Smart Assistant
    K212837 ProxiDiagnost N90
    K210692 DigitalDiagnost
    K203087 CombiDiagnost R90
    K202564 DigitalDiagnost C90
    K182973 DigitalDiagnost C90
    Search all 18 clearances from Philips Medical Systems Dmc GmbH →