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510(k) Data Aggregation

    K Number
    K181292
    Device Name
    PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor
    Manufacturer
    Cogentix Medical, Inc.
    Date Cleared
    2018-11-15

    (183 days)

    Product Code
    EOX, EOB, EOQ, FAJ, OCS
    Regulation Number
    874.4710
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cogentix Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PrimeSight™ UNITY 9000 Series Video Processors, when used in conjunction with a Cogentix Medical flexible videoscope, are indicated for the display and management of video and images during trans-nasal esophagoscopy, cystoscopy, bronchoscopy and nasopharyngoscopy procedures.
    Device Description
    The PrimeSight™ UNITY 9000 and PrimeSight™ UNITY 9100 Video Processors (herein referred to as "UNITY 9000", "UNITY 9000 Processor" or "UNITY 9000 Series Video Processors") are video processing units designed to work exclusively with the Cogentix Medical TNE-5000, CST-5000, CST-5000i. BRS-5100 and ENT-5000 models of flexible videoscopes (herein referred to as "5000 Series Videoscopes") to display images and videos during endoscopic procedures. The UNITY 9000 Processor consists of two modules which are physically connected with a hinge mechanism. The all-inone computer (AIO PC) unit is used for the presentation and display of images and includes a large 19'' wide screen display with an integrated touchscreen. The Camera Interface Module (CIM) base unit allows for the connection of a videoscope or camera to the Processor, as well as any endoscopic peripherals being used during the procedure, as well as image processing. There are two different model configurations available for the UNITY 9000. These models are offered specific to the type of endoscopic procedure being performed. The Base Configuration model (UVP-9000) supports urology and bronchoscopy applications, while the Airway Configuration model (UVP-9100) offers an integrated air pump for trans-nasal esophagoscopy and a stroboscopy interface for use during Ear, Nose, and Throat (ENT) stroboscopy examinations.
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