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510(k) Data Aggregation

    K Number
    K091269
    Device Name
    NEUROPET
    Manufacturer
    PHOTODETECTION SYSTEMS, INC.
    Date Cleared
    2009-05-08

    (8 days)

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

    PHOTODETECTION SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a Positron Emission Tomography (PET) system used to detect and display the distribution of positron emitting radionuclides in parts of the human body that will fit in the patient aperture. This device is to be used by trained healthcare professionals. This information can assist in research, diagnosis, therapeutic planning and therapeutic outcome assessment.
    Device Description
    The PhotoDetection Systems' NeuroPET is a small aperture positron emission tomography PET scanner that produces images based on the distribution of positron emitting isotopes in parts of the human body that will fit in the patient aperture for medical diagnostic and research purposes. The NeuroPET system consists of three subsystems (shown below); the NeuroPET Ring Gantry/Acquisition System, Patient Table and the Console/PC. The NeuroPET Ring detects coincident gamma pairs emitted from positron annihilation and contains all the data acquisition electronics and reconstruction computers. The Patient Table is used to comfortably position the patient relative to the scanner. The Console/PC provides the operator interface for the system including such functions as system and scan control, reconstruction, data archiving, image viewing, analysis, and network connectivity.
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