BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇬 Singapore

    RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4

    K Number: K071054 · Decision May 22, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    5
    Review Days
    36

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    Basic Information

    Device Name
    RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4
    K Number
    K071054
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Volume Interactions Pte, Ltd.
    Date Received
    April 16, 2007
    Decision Date
    May 22, 2007
    Product Code
    LLZ
    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
    LLZ System, Image Processing, Radiological

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    Other Clearances by Volume Interactions Pte, Ltd.

    K Number Device Name
    K063730 DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0
    K053162 DEXTROSCOPE & DEXTROBEAM
    K032924 RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3
    K022938 VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3