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510(k) Data Aggregation

    K Number
    K221984
    Device Name
    InterView XP; InterView FUSION
    Date Cleared
    2023-03-29

    (266 days)

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

    Mediso Medical Imaging Systems, LTtd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    InterView XP is a Software as Medical Device (SaMD) aimed at reviewing medical images such as planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, Gated SPECT) acquired by gamma cameras. Review of other image modalities is also supported. Common Users for clinical purposes are trained medical professionals, including clinicians and technicians in hospitals or imaging centers. Software components provide functions for image display, manipulation, enhancements, analysis and quantification. This device is not indicated for mammography use or dental diagnostics. The software provides diagnostic information, however, diagnostic decision cannot be based solely on the software. InterView XP has no specific target population. InterView FUSION is a Software as Medical Device (SaMD) aimed at reviewing medical images such as planar scans and tomographic scans from SPECT, PET, CT, and MRI modalities. Review of other image modalities is also supported. The common users for clinical purposes are trained medical professionals, including clinicians in hospitals or imaging centers. Software components provide functions for image display, manipulation, enhancements, analysis, and quantification. This device is not indicated for mammography use or dental diagnostics. The software provides diagnostic information - however, diagnostic decisions cannot be based solely on this software. InterView FUSION has no specific target population.
    Device Description
    InterView XP is a DICOM image visualization and post-processing Software as Medical Device (SaMD). It is a standalone medical device. Developed by Medical Imaging Systems, built on state-of-the-art technologies, providing evaluation method according to the international guidelines for planar, whole body and SPECT nuclear medicine applications. The product is designed as a software only product, operating on Windows based OS. The software inputs are images of nuclear medicine studies that are DICOM 3.0 compatible and uploaded into the user's computer and the Software will process the images in multiple ways to achieve the image analysis by the user's demands. InterView FUSION is a multi-modal visualization and evaluation software. Developed by Mediso built on state-of-the-art technologies, novel image processing algorithms and tools for evaluating different medical imaging modalities. The product is designed as a standalone software, i.e. Software as Medical Device (SaMD) product, operating on Windows OS as a classical user application.
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