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510(k) Data Aggregation

    K Number
    K180514
    Device Name
    VERITON NM
    Manufacturer
    Spectrum Dynamics Medical Ltd.
    Date Cleared
    2018-04-25

    (57 days)

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

    Spectrum Dynamics Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VERITON™ NM is a Nuclear Medicine (NM) imaging system, intended to perform general nuclear medicine imaging procedures for the detection of radioisotope tracer uptake in a patient's body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. Scanning modes include whole body and tomographic (static, dynamic and multi-gated) mode, while acquisition types include single and multi-isotope single-photon imaging-enhancement features include gating by way of physiological signals and real-time automatic body contouring. The VERITON™ NM system is a medical device intended for use by appropriately-trained healthcare professionals to aid in the detection, localization and diagnosis of diseases and organ function, for the evaluation of diseases, trauma, abnormalities and disorders. System output can be used by a physician for planning, guiding, and monitoring therapy. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: whole body imaging and tomographic imaging. Software: System application software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, CT and other imaging modalities.
    Device Description
    Spectrum Dynamics VERITON™ NM system is a single photon emission computing tomography system (SPECT) intended for detection of radioisotope tracer uptake in the body and to produce cross-sectional images through computer reconstruction of the data. The system uses a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The system may utilize various modalities to create attenuation corrected images along with functional and anatomical mapping imaging (localization, registration and fusion). The VERITON™ NM system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to obtain additional images, imaging planes, analysis results and uptake quantitation. The system may be used for patients of all ages.
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