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510(k) Data Aggregation

    K Number
    K110108
    Device Name
    MODALIXX
    Manufacturer
    Date Cleared
    2011-03-16

    (61 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMPRONIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MODALIXX G202MP display is intended for use by physicians and the medical industry for diagnostic imaging applications along with the Picture Archiving Communication System (PACS). The Modalixx G202MP is also intended as a direct replacement for ageing CRT medical monitors. The MODALIXX G202MP display is intended to be used in displaying and viewing digital images for review by trained medical practitioners before the digital images are sent to other diagnostic displays. Modalixx G202MP is not meant to be used for mammography applications.
    Device Description
    Modalixx G202MP is a grayscale High Bright medical LCD solution for modality CRT monitor replacement. G202MP will Auto Sync to any legacy grayscale or color analog modality and up scales it to clear, sharp, and vivid high bright 2 mega pixel resolution to provide the best diagnostic medical imaging applications. Armed with a complete set of input options, G202MP is compatible to nearly all medical modality applications. Modalixx G202MP medical LCD is capable of accepting any combination of BNC connections, including single to 5 BNC, as well as D-SUB 15. At any resolution from 525- 1600 horizontal pixels, G202MP can accept from low line to high line video signals through BNCs or VGA (D-sub15) inputs. This attribute of the Modalixx G202MP can be utilized in different types of medical imaging and application modalities as a true CRT imaging replacement.
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