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510(k) Data Aggregation

    K Number
    K241751
    Device Name
    NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat
    Manufacturer
    Date Cleared
    2024-07-15

    (27 days)

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

    Positrigo AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NeuroLF is a positron emission tomography system that is used to detect and display the distribution of positron-emitting radionuclides within parts of the human body to assist in diagnosis, therapeutic planning, and therapeutic outcome assessment. The NeuroLF seat is intended to properly position the patient for PET imaging of the neck or head with the NeuroLF.
    Device Description
    The NeuroLF is a small aperture Positron Emission Tomography (PET) scanner that produces images of the distribution of positron-emitting isotopes from parts of a subject that are put into the aperture for medical diagnostic purposes. The NeuroLF System comprises the Scanning Unit and the Patient Positioning System (NeuroLF Seat). The circular opening in the scanner head has an effective inner diameter of 260mm and is designed such that the entire brain fits within the scanner's field of view (FoV). With a length of an axial FoV of 163mm, the NeuroLF is designed to capture a single image. The NeuroLF scanner head consists of an octagonal detector, which is composed of 8 detector module contains a total of 384 Lutetium Yttrium Orthosilicate (LYSO) Crystals. The software of the NeuroLF System integrates the equipment, allows acquisition, reconstruction and export of tomographic images. It also allows the user to detect the current state of the running system. The device shall only be used with patients whose weight is lower than 200kg (440lb). There are three different versions of the NeuroLF; 10 mm (NeuroLF Basic), 15 mm (NeuroLF Pro) and 20 mm (NeuroLF Advanced). The number corresponds to the length of the LYSO crystals in the detector modules. The absorption probability of gamma radiation is proportional to the volume of scintillating material in the scanner and therefore the highest absorption probability is to be expected from the 20 mm detectors. The longer the LYSO crystals the higher the sensitivity of the device, therefore in clinical use the acquisition time or the activity in the field of view could be reduced.
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