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510(k) Data Aggregation

    K Number
    K092204
    Device Name
    PMD VIEWER
    Manufacturer
    SPENCER TECHNOLOGIES
    Date Cleared
    2009-10-08

    (78 days)

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

    SPENCER TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PMD Viewer Software is intended to provide off-line data viewing, playback, and report generation features of transcranial TCD100M/PMD150 Doppler ultrasound studies on a PC. PMD Viewer may only be operated independently, as a software-only product. PMD Viewer is intended for use by a technologist or physician trained in the use of Doppler ultrasound. PMD Viewer is NOT intended to replace any means of evaluating vital patient physiological processes. No new intended uses are claimed.
    Device Description
    This device is a software-only version of the Spencer Technologies digital Transcranial Doppler ultrasound system, the TCD100M/PMD150, and is described as the PMD Viewer. The modification of the TCD100M/PMD150 implemented in the PMD Viewer provides physicians and technologists with the same data viewing, playback, and report generation features of the TCD100M/PMD150 off-line on a standard PC utilizing Windows XP SP2 or VISTA. All software features can be controlled with a standard keyboard and wheel mouse. Because it can read the proprietary binary file formats of the predicate (parent) device, the TCD100M/PMD150, the PMD Viewer displays images without any compression, duplicating the original quality of the images on the TCD100M/PMD150.
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    K Number
    K002533
    Device Name
    TCD 100M, PWD13 TRANSDUCER
    Manufacturer
    SPENCER TECHNOLOGIES
    Date Cleared
    2000-08-30

    (14 days)

    Product Code
    IYN
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPENCER TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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