Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K110507
    Device Name
    CARDIAC SCANNER AND PROCESSING SYSTEM
    Manufacturer
    SPECTRUM DYNAMICS (ISRAEL) LTD.
    Date Cleared
    2011-07-13

    (141 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECTRUM DYNAMICS (ISRAEL) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The D-SPECT™ Cardiac Scanner System is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The D-SPECTTM Cardiac Scanner System includes display equipment, patient and equipment supports, component parts, and accessories. D-SPECT™ Cardiac Scanner System is primarily intended, but not limited to, cardiac applications. D-SPECT™ Cardiac Scanner System supports radionuclides within the energy range of 40-170 keV. The D-SPECT™ Cardiac Scanner System supports acquisition and imaging modes such as, but not limited to, SPECT (Single Photon Emission Computed Tomography), Multi-Gated SPECT and features low count rate (low dose) acquisition, with no lose in image quality. D-SPECT™ Cardiac Scanner System is intended for Processing, Reporting, Archiving, Display, Communication and analysis of SPECT data, using tools for imaging and fully automated review and quantification of Cardiac SPECT data including Quantitative Perfusion SPECT (QPS), Quantitative Gated SPECT (QGS) and Quantitative Blood Pool Gated SPECT (QBS).
    Device Description
    Spectrum Dynamics' D-SPECT™ Cardiac Scanner System is a SPECT device, which is designed to perform myocardial perfusion imaging. The device is comprised of a detector head, gantry, and patient chair. Device operation is controlled from an acquisition station console. The system is supported by use of data-transfer accessories (RFID tags), which are attached to the patient's wrist, for patient and radiopharmaceutical agent positive identification. The cardiac gamma camera is designed such that there are no external moving parts that surround the patient. Detector modules rotate within the closed detector head. The special scanning geometry and detector technology enable shorter scan times. Additionally, a new revision of software was developed, adding Archiving, Display and Communication capabilities (NEMA standard DICOM protocol) with external processing stations PACS systems. The new software package also features correction of insignificant bugs discovered since last release. The modified D-SPECT™ Cardiac Scanner System include a Processing workstation. The Processing Workstation, which is part of the imaging system, is equipped with software package for Processing, Archiving, Display, Communication and analysis of emission computerized tomography data using tools for imaging and fully automated review and quantification of Cardiac SPECT data including the Cedars Sinai Quantitative Perfusion SPECT (QPS), Quantitative Gated SPECT (QGS) and Quantitative Blood Pool Gated SPECT (QBS) software.
    Ask a Question

    Page 1 of 1