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510(k) Data Aggregation

    K Number
    K202718
    Device Name
    Qmenta Care Platform Family
    Date Cleared
    2021-06-16

    (272 days)

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

    Mint Labs, Inc., d/b/a. QMENTA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    QMENTA Care Platform Family is a software medical imaging system used to receive DICOM images and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. QMENTA Care Platform Family consists of two components: 1. A Storage/archiving server for the retrieval of DICOM images from CT and MR modality data, and also PET/CT data from PACS and/or OS-based file storage. 2. A workflow server that allows to integrate legally marketed applications for clinical use into the OMENTA Care Platform Family. The applications are geared toward specific types of image analysis and are marketed with corresponding names. The results may be saved to a DICOM image file and may be further visualized on an imaging workstation. QMENTA Care Platform Family is designed to aid suitably qualified physicians, who will base their diagnoses on training and protocols that do not necessarily rely on image maps or image quantifications.
    Device Description
    QMENTA Care Platform Family (QMENTA Care) is a software medical imaging system that runs on standard computer hardware that may compute legally marketed applications for clinical use based on DICOM images captured via MR, CT and PET modalities. These actions include: - Retrieval of MR, CT and PET DICOM image studies from PACS and/or OS-based file storage - . Computation of legally marketed applications for clinical use - Generation of reports summarizing the computations performed The resulting output may be provided in a standard DICOM format as additional MR series with possible computed outputs (image overlays, numerical reports, and/or other results) that can be displayed on third-party DICOM workstations and Picture Archive and Communications Systems (PACS). From a workflow perspective, QMENTA Care can operate as a computing appliance that is capable of supporting DICOM file transfer for input and output of results. The legally marketed applications for clinical use can be "plugged in" into the QMENTA Care Platform Family. The applications may be geared toward specific types of image analysis and may be marketed with corresponding names.
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