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510(k) Data Aggregation

    K Number
    K040741
    Device Name
    ULTRASOUND LOCALIZATION SYSTEM ULS 0142
    Manufacturer
    HMT HIGH MEDICAL TECHNOLOGIES AG
    Date Cleared
    2004-08-19

    (149 days)

    Product Code
    LNSREG
    Regulation Number
    876.5990
    Why did this record match?
    Applicant Name (Manufacturer) :

    HMT HIGH MEDICAL TECHNOLOGIES AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ULS0142 accessory is indicated for ultrasound localization of a target stone prior to extracorporeal shock wave lithotripsy with the LithoDiamond LTFS230. The ULS0142 is not indicated for use as a stand-alone diagnostic ultrasound system, and should only be used for lithotripsy-related applications.
    Device Description
    The ULS0142 accessory is an adjunct ultrasound localization system for use prior to extracorporeal shock wave lithotripsy with the LithoDiamond LTFS230. The ULS0142 is not indicated for use as a stand-alone diagnostic ultrasound system, and should only be used for lithotripsy-related applications.
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