BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Aquarius 8600 1417WCI; Aquarius 8600 1717WCI

    K Number: K173273 · Decision Nov 9, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    19
    Review Days
    28

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    Basic Information

    Device Name
    Aquarius 8600 1417WCI; Aquarius 8600 1717WCI
    K Number
    K173273
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imaging Dynamics Company , Ltd.
    Date Received
    October 12, 2017
    Decision Date
    November 9, 2017
    Product Code
    MQB
    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
    MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

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    Other Clearances by Imaging Dynamics Company , Ltd.

    K Number Device Name
    K171169 Aquarius 8600 1417TG and Aquarius 8600 1717TG
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    K170202 Aquarius 8600
    K111098 INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN
    K071401 X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM
    K071408 X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECTOR
    K071403 X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM
    K071402 X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM
    K071409 X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM
    K070079 X3C DIGITAL RADIOGRAPHIC DETECTOR
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