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510(k) Data Aggregation

    K Number
    K160120
    Device Name
    D-SPECT Processing and Reviewing Workstation
    Manufacturer
    SPECTRUM DYNAMICS LTD.
    Date Cleared
    2016-03-21

    (62 days)

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

    SPECTRUM DYNAMICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The D-SPECT® Processing and Reviewing Workstation is intended for Processing, Reporting, Archiving, Display, Communication and Analysis of emission computerized tomography data using tools for imaging and automated review and quantification of Cardiac SPECT data. The D-SPECT® Processing and Reviewing Workstation is intended to work with Spectrum Dynamics' D-SPECT® Cardiac Scanner System or as a separate standalone post processing workstation. The system is intended for use by the Nuclear Medicine (NM), Radiology or Electro Physiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NMI data, including planar scans (Static, Dynamic, Multi-Gated) and tomographic three-dimensional scans (SPECT, Gated SPECT) acquired by gamma cameras. The system can run on a dedicated workstation or as part of Spectrum Dynamics' D-SPECT® Cardiac Scanner System. The NM data can be coupled with registered and/or fused X-Ray CT or MR scans, and with physiological signals in order to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes. "SUMO" optional application enables visual evaluation and assessment of the sympathetic innervation system of the heart by quantification of uptake ratios between regions of interest, identifying discreet uptake areas of mIBG I-123 (AdreView tm Iobenguane I-123 Injection) or similar agents within the heart.
    Device Description
    D-SPECT® Processing and Reviewing Workstation is intended for acceptance, transfer, display, storage, and processing of images for detection of radioisotope tracer uptakes in the patient's body. The device using various processing modes supported by the various clinical applications and various features designed to enhance image quality. The emission computerized tomography data can be coupled with registered and/or fused CT/MR scans and with physiological signals in order to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes. Visualization tools include segmentation, color coding, and polar maps. Analysis tools include Quantitative Perfusion SPECT (QPS), Quantitative Gated SPECT (QGS) and Quantitative Blood Pool Gated SPECT (QBS) measurements, Multi Gated Acquisition (MUGA) and Heart-to-Mediastinum activity ratio (H/M). It also includes reporting tools for formatting findings and user selected areas of interest. It is capable of processing and displaying the acquired information in traditional formats, as well as in three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs. D-SPECT® Processing and Reviewing Workstation is based on Windows operating system. Due to special customer requirements and the clinical focus the D-SPECT® Processing and Reviewing Workstation can be configured in the same way as the predicate device with different combinations of Windows OS based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages. D-SPECT® Processing and Reviewing Workstation is a processing workstation primarily intended for, but not limited to cardiac applications. The workstation can be a part of the FDA cleared D-SPECT® Cardiac Scanner System (K110507) or integrated to a separate standalone post processing station. "SUMO" optional application enables visual evaluation and assessment of the sympathetic innervation system of the heart by quantification of uptake ratios between regions of interest, identifying discreet uptake areas within the heart of mIBG I-123 (AdreView™ Iobenguane I-123 Injection) or similar agents.
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    K Number
    K072468
    Device Name
    MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM
    Manufacturer
    SPECTRUM DYNAMICS LTD.
    Date Cleared
    2007-10-01

    (27 days)

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

    SPECTRUM DYNAMICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    D-SPECT 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 device includes display equipment, patient and equipment supports, component parts, and accessories. D-SPECT is primarily intended for cardiac applications. D-SPECT supports radionuclides within the energy range of 40 -170 keV.
    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 and to the syringe containing the radiopharmaceutical agent, for patient and syringe positive identification. The cardiac gamma camera is designed such that there are no external moving parts that surround the patient. Detector boards rotate within the closed detector head. The special scanning geometry and detector technology, enable shorter scan times. In the modified D-Spect™ device, a Processing Station was added. The Processing Station, which is part of the display equipment, contains a software application with the Cedars Sinai Quantitative Perfusion SPECT (QPS) and Quantitative Gated SPECT (QGS) software that enables a review and quantification of cardiac SPECT data.
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    K Number
    K062450
    Device Name
    D-SPECT CARDIAC SCANNER SYSTEM
    Manufacturer
    SPECTRUM DYNAMICS LTD.
    Date Cleared
    2006-10-20

    (59 days)

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

    SPECTRUM DYNAMICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    D-SPECT 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 device includes display equipment, patient and equipment supports, component parts, and accessories. D-SPECT is primarily intended for cardiac applications. D-SPECT supports radionuclides within the energy range of 40 -170 keV.
    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 and to the syringe containing the radio-pharmaceutical agent, for patient and syringe positive identification. The cardiac gamma camera is designed such that there are no external moving parts that surround the patient. Detector boards rotate within the closed detector head. The special scanning geometry and detector technology, enable shorter scan times.
    Ask a Question

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