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510(k) Data Aggregation

    K Number
    K010509
    Device Name
    CEDARS-SINAI BPGS AND MOCO
    Manufacturer
    SMV AMERICA
    Date Cleared
    2001-04-27

    (65 days)

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

    SMV AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003358
    Device Name
    QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)
    Manufacturer
    SMV AMERICA
    Date Cleared
    2001-01-19

    (85 days)

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

    SMV AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002553
    Device Name
    DS DS I-SERIES
    Manufacturer
    SMV AMERICA
    Date Cleared
    2000-09-15

    (29 days)

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

    SMV AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001681
    Device Name
    POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM
    Manufacturer
    SMV AMERICA
    Date Cleared
    2000-08-25

    (85 days)

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

    SMV AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991565
    Device Name
    TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S
    Manufacturer
    SMV AMERICA
    Date Cleared
    1999-08-02

    (89 days)

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

    SMV AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SMV TAC-2 accessory to the SMV dual head emission tomographic systems produces images of a patient's anatomy when performing cardiac or wholebody imaging in single photon mode, or in coincidence mode (using the VCR option) . The system is intended to provide an enhancement to the emission images by compensating for the attenuation effects of the human body.
    Device Description
    The TAC-2 hardware consists of two sliding line source emitter block/collimator assemblies. Each assembly extends transaxially across the face of each detector of a DST series gamma camera oriented 180°. When in use each emitter block exposes the collimator in the opposing assembly. The assemblies travel in synchrony along the axial direction.
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    K Number
    K972686
    Device Name
    VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER
    Manufacturer
    SMV AMERICA
    Date Cleared
    1997-10-14

    (89 days)

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

    SMV AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VCAR option to the DST Gamma Camera and VISION Powerstation and the VCAR option to the DST-XL Gamma Camera and VISION Powerstation produce images which depict the anatomical distribution of radioisotopes within the human body, for interpretation by medical clinicians. The systems are intended for whole body nuclear imaging. Indication for use of the VCR option to the DST and DST-XL cameras and Powerstation computer is an accessory upgrade intended to perform electronic collimation for coincidence imaging of positron-emitting radioisotopes in the human body.
    Device Description
    The VCAR option to the DST Gamma Camera and VISION Powerstation (DST&PS/VCAR) and the VCAR option to the DST-XL Gamma Camera and VISION Powerstation are accessory upgrades to the previously cleared DST an DST-XL Gamma Cameras (K921008) and VISION Powerstation (K912753). This accessory enables the system to perform electronic collimation for positron emission tomography (PET) of radioisotopes within the human body. The DST&PS/VCAR and DST-XL&PS/VCAR utilize proprietary coincidence detection electronics and software to perform electronic collimation of gamma rays emitted from decay of radioisotopes in a patient. This process is called "Coincident Photon Emission Computed Tomography" (CPECT). The DST&PS/VCAR and DST-XL&PS/VCAR allows the operator to acquire coincidence imaging data by controlling the detector electronics and processors in coincidence imaging mode. The DST&PS/VCAR and DST-XL&PS/VCAR also includes the control, processing, and display screens to perform reconstruction of 2-D and 3-D information from the acquired datasets.
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    K Number
    K963273
    Device Name
    VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION
    Manufacturer
    SMV AMERICA
    Date Cleared
    1997-03-11

    (203 days)

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

    SMV AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VCAR option to the VISION FX-80 Gamma Camera and Power Station produces images which depict the anatomical distribution of radioisotopes within the human body, for interpretation by medical clinicians. The system is intended for whole body nuclear imaging.
    Device Description
    The VCAR option to the VISION FX-80 Gamma Camera and Power Station (FX-80&PS/VCAR) is an accessory upgrade to the previously cleared FX-80 Gamma Camera (K935273) and Power Station (K912753). This accessory enables the system to perform electronic collimation for positron emission tomography (PET) of radioisotopes within the human body. The FX-80&PS/VCAR utilizes proprietary coincidence detection electronics and software to perform electronic collimation of gamma rays emitted from decay of radioisotopes in a patient. This process is called "Coincident Photon Emission Computed Tomography" (CPECT). The FX-80&PS/VCAR allows the operator to acquire coincidence imaging data by controlling the detector electronics and processors in coincidence imaging mode. The FX-80&PS/VCAR also includes the control, processing, and display screens to perform reconstruction of 2-D and 3-D information from the acquired datasets.
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