BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MASTER3DS

    K Number: K082410 · Decision Oct 31, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    133
    Applicant Total
    7
    Review Days
    71

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    Basic Information

    Device Name
    MASTER3DS
    K Number
    K082410
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    E-Woo Technology
    Date Received
    August 21, 2008
    Decision Date
    October 31, 2008
    Product Code
    OAS
    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
    OAS X-Ray, Tomography, Computed, Dental

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    Other Clearances by E-Woo Technology

    K Number Device Name
    K091090 DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717
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    K090991 COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO
    K090171 COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D
    K081847 PICASSO MASTER, ECT AND MASTER 3D
    K070658 DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM