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510(k) Data Aggregation

    K Number
    K193149
    Device Name
    True 3D Viewer Software
    Manufacturer
    EchoPixel Inc.
    Date Cleared
    2019-12-27

    (44 days)

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

    EchoPixel Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI, XA and Ultrasound sources. It is also intended as software which provides visual information to be used by the health care professional for analysis of surgical options, and the intraoperative display of the mentioned images. The True 3D Viewer software is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
    Device Description
    Not Found
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    K Number
    K170167
    Device Name
    True 3D Viewer Software
    Manufacturer
    EchoPixel Inc.
    Date Cleared
    2017-03-03

    (43 days)

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

    EchoPixel Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI and Ultrasound sources. It is also intended as software for pre-operative analysis of surgical options. The True 3D Viewer Software is designed for use only with performance tested hardware specified in the user documentation. The device is intended to be used by health care professionals, who are responsible for making all final patient management decisions.
    Device Description
    The True 3D Viewer Software is a software application that enables a Health Care Professional (HCP) to visualize and interact with DICOM image data, from CT, MRI and Ultrasound imaging modalities, to assist in clinical decision making. The application loads DICOM image data and presents a stereoscopic 3D rendered view of the DICOM image data. The True 3D Viewer Software application enables HCPs to visualize and interact with image data and depictions of tissue and organs in an open 3D space as if they were real physical objects. The objects that the software will display are 2D MPR images, 3D volumes, 3D surfaces, labels, and measurements. The system is intended for use in the clinic or hospital settings. Information on performance tested hardware that is provided by the user is described in product labeling.
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