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510(k) Data Aggregation

    K Number
    K233572
    Device Name
    Autofuse
    Manufacturer
    Date Cleared
    2024-03-06

    (121 days)

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

    Pymedix

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Autofuse is a software package that provides physicians a means for comparison of medical data including imaging data that is DICOM compliant. It allows the display, annotation, volume operation, volume rendering, registration and fusion of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning, and other medical specialties. Autofuse is not intended for mammography.
    Device Description
    Autofuse is a software application providing relevant tools for Radiotherapy professionals to use while creating treatment plans. The Autofuse device is a Picture Archiving and Communication System (medical imaging software). Autofuse provides medical image processing designed to facilitate the oncology or other clinical specialty workflow by allowing the comparison of medical imaging data from different modalities, points in time, and / or scanning protocols. The product provides users with the means to display, co-register and analyze medical images from multiple modalities including PET, CT, RT Dose and MR; draw Regions of Interest (ROI); and import / export results to/from commercially available radiation treatment planning systems and PACS devices. Co-registration includes deformable registration technology that can be applied to DICOM data including diagnostic and planning image volumes, structures, and dose. Autofuse is used as a stand-alone application on recommended Off-The-Shelf (OTS) computers supplied by the company or by the end-user.
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