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510(k) Data Aggregation

    K Number
    K172768
    Device Name
    ZOOM
    Manufacturer
    Zetta Medical Technologies, LLC.
    Date Cleared
    2018-04-24

    (223 days)

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

    Zetta Medical Technologies, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ZOOM Image Enhancement System is an image processing software that can be used for image enhancement in MRI images. Enhanced images will be sent to PACS server and exist in conjunction to the original images.
    Device Description
    ZOOM Image Enhancement System is an image processing software that can be used for image enhancement in MRI images. ZOOM image enhancement software implements a noise reduction algorithm using wavelets and image guided filtering. Original images are decomposed into different wavelet sub bands and noise in each band is soft threshold. De-noised images are reconstructed from softthresholded images using inverse wavelet transform. The software, which is installed on a remote computer, receives DICOM images from MRI host computer, automatically processes the received images and sends the enhanced images to a PACS server. Enhanced images exist in conjunction to the original images.
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    K Number
    K170273
    Device Name
    Z-DOSE29
    Manufacturer
    ZETTA MEDICAL TECHNOLOGIES, LLC.
    Date Cleared
    2017-04-28

    (88 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZETTA MEDICAL TECHNOLOGIES, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Z-DOSE29 Dose Check system is intended to provide dose check features to Computed Tomography systems. Z-DOSE29 software extracts CTDI values from CT host computer's screen, compares it to predefined thresholds, and sends notification and alert messages to the CT scanner display monitor prior to scanning.
    Device Description
    Z-DOSE29 Dose Check provides the Dose Check feature to CT scanners as specified by the NEMA XR-25 standard and the Dose Check feature of NEMA XR-29*. This includes both Dose Notifications (for individual series) and Dose Alerts (for accumulated dose). The Z-DOSE29 Dose Check software, which is installed on a remote computer that resides on the same local area network as the CT host computer, receives DICOM images from the CT host computer. The software captures CTDI values for each prescribed CT series, compares the values to AAPM dose check guideline (version 1.0) values and displays notification message(s) on the CT scanner operator's console. The Z-DOSE29 Dose Check software also adds the CTDI values from the individual series and displays alert message(s) on the CT scanner operator's console if the accumulated CTDI value exceeds a predefined ALERT threshold. *NEMA XR-29 incorporates NEMA XR-25 Dose Check feature In the event of an Alert, and in addition to displaying the alert message to the CT operator, Z-DOSE29 utilizes a relay to disable scanning until a correct password is inputted by the CT operator. The Z-DOSE29 Dose Check software also records CTDI values and CT exam information into a local a database. Information in the database can be accessed by authorized users via a web browser. The Z-DOSE29 Dose Check software runs on a Windows operating system 10 with a .net framework 4.0 or higher version.
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    K Number
    K160852
    Device Name
    Zia
    Manufacturer
    Zetta Medical Technologies, LLC.
    Date Cleared
    2016-12-15

    (262 days)

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

    Zetta Medical Technologies, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zia™ Image Enhancement System is an image processing software that can be used for reducing noise in CT images. Enhanced images will be uploaded back to host/PACS systems and exist in conjunction to the original images. Zia™ is not intended for mammography applications. The device processing is not effective for lesion, mass, or abnormalities of sizes less than 2mm.
    Device Description
    Zia™ Image Enhancement System is an image processing software that can be used for reducing noise in CT images. Zia™ image enhancement software is based on a core noise reduction algorithm that reduces noise in flat regions via a regularization process while keeping the edges via data fidelity constrains. The software, which is installed on a remote computer, receives DICOM images from CT host computer (Zia DICOM node needs to be configured on the scanner), automatically processes the received images and uploads the post processed images back on to the host computer and/or other PACS systems. Enhanced images exist in conjunction to the original images.
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