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

    MultiScan G-Arm System

    K Number: K151280 · Decision Sep 30, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    81
    Applicant Total
    6
    Review Days
    139

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    Basic Information

    Device Name
    MultiScan G-Arm System
    K Number
    K151280
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beijing East Whale Imaging Technology Co., Ltd.
    Date Received
    May 14, 2015
    Decision Date
    September 30, 2015
    Product Code
    OXO
    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
    OXO Image-Intensified Fluoroscopic X-Ray System, Mobile

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    Other Clearances by Beijing East Whale Imaging Technology Co., Ltd.

    K Number Device Name
    K163429 B6
    K160984 MultiScan G-Arm System
    K160343 SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner
    K141672 DIGIARC 100AU+
    K131423 G-ARM MULTISCAN SYSTEM