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510(k) Data Aggregation

    K Number
    K970813
    Device Name
    DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111
    Manufacturer
    DENVU, INC.
    Date Cleared
    1997-05-08

    (64 days)

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

    DENVU, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DIMS (Digital Imaging and Medical System) is intended to be used as a picture archiving and communications system during colposcopy procedures.
    Device Description
    The DIMS (Digital Imaging and Medical System) is a picture archiving and communications system. Hardware components are purchased from other manufacturers. Two models will be provided, distinguished only by the size of their monitors. Software runs in the Windows 95 format.
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