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510(k) Data Aggregation

    K Number
    K162344
    Device Name
    INNOLUX RIC
    Manufacturer
    INNOLUX CORPORATION
    Date Cleared
    2016-12-20

    (120 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOLUX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wireless/Wired INNOLUX RIC flat panel detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The INNOLUX RIC is not intended for mammography, fluoroscopy, tomography, and angiography applications.
    Device Description
    The INNOLUX RIC Flat Panel Detector is a portable digital detector that integrated with an operating PC and an X-ray generator to acquire and digitize x-ray exposures from, standard radiographic systems and transfer for radiography diagnostic. The INNOLUX RIC is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults, pediatrics and neonates. The detector models support both wireless and wired data communication. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams.
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