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

    ALARA T210 COMPUTED RADIOGRAPHY SYSTEM

    K Number: K102479 · Decision Jun 2, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    6
    Review Days
    276

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    Basic Information

    Device Name
    ALARA T210 COMPUTED RADIOGRAPHY SYSTEM
    K Number
    K102479
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alara, Inc.
    Date Received
    August 30, 2010
    Decision Date
    June 2, 2011
    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 Alara, Inc.

    K Number Device Name
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    K062390 CRYSTALVIEW R200
    K061538 ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200
    K032210 ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM
    K000162 METRISCAN BONE DENSITY SYSTEM