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

    DEXTROSCOPE & DEXTROBEAM

    K Number: K053162 · Decision Dec 9, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    5
    Review Days
    25

    Basic Information

    Device Name
    DEXTROSCOPE & DEXTROBEAM
    K Number
    K053162
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    VOLUME INTERACTIONS PTE LTD
    Date Received
    November 14, 2005
    Decision Date
    December 9, 2005
    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
    K071054 RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4
    K063730 DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0
    K032924 RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3
    K022938 VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3