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510(k) Data Aggregation

    K Number
    K120525
    Device Name
    QLAB QUANTIFICATION SOFTWARE
    Manufacturer
    PHILIPS HEALTHCARE GROUP
    Date Cleared
    2012-03-09

    (16 days)

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

    PHILIPS HEALTHCARE GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QLAB Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
    Device Description
    OLAB Quantification software is available either as a stand-alone product that can function on a standard.PC, on board a dedicated workstation, or on-board Philips' ultrasound systems. It can be used by trained healthcare professionals for the on-line and off-line review and quantification of ultrasound studies in healthcare facilities/hospitals. The QLAB Quantification software application package is designed to view and quantify image data acquired on Philips ultrasound products. Cardiac Motion Quantification (CMQ) is a plug-in included in Philips QLAB Quantification software. The CMO plug-in is an application within OLAB intended to provide cardiac motion quantification. OLAB Quantification software is intended for use in healthcare facilities/hospitals by trained healthcare professionals. OLAB CMO modifications were implemented to provide clients with improved reproducibility and consistency between users, as well as to provide users with a reduction of workflow steps. The modifications described in this Special 510(k) submission do not alter the intended use of the OLAB Quantification software with the CMO plug-in.
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