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510(k) Data Aggregation

    K Number
    K993532
    Device Name
    DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST OTHER NAMES)
    Manufacturer
    IMPAX TECHNOLOGY, INC.
    Date Cleared
    1999-12-15

    (57 days)

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

    IMPAX TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DDS software is combined with appropriate hardware to form a diagnostic review station. DDS is used to display and manipulate patient images and demographic information, for diagnostic, review and referral purposes. It is a software package which may be marketed as a software only solution, or in conjunction with standard hardware. DDS can be used as a stand-alone system or in connection with a larger system.
    Device Description
    DDS software is combined with appropriate hardware to form a diagnostic review station. DDS is used to display and manipulate patient images and demographic information, for diagnostic, review and referral purposes. It is a software package which may be marketed as a software only solution, or in conjunction with standard hardware. DDS can be used as a stand-alone system or in connection with a larger system.
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