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510(k) Data Aggregation

    K Number
    K122289
    Device Name
    IMAGE-COM 5.0
    Manufacturer
    TOM TEC IMAGING SYSTEMS GMBH
    Date Cleared
    2012-10-24

    (86 days)

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

    TOM TEC IMAGING SYSTEMS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Image-Com software is intended for reviewing and measuring of digital medical data of different modalities. It can be driven by Image-Arena or other third party platforms and is intended to launch other commercially available analysis and quantification tools.
    Device Description
    Image-Com is a clinical application package software for reviewing and measuring of digital medical data. Image-Com is either embedded in Image-Arena™ platform or can be integrated into Third Party platforms, such as PACS or CVIS.
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