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510(k) Data Aggregation

    K Number
    K232569
    Device Name
    CAREMIBRAIN
    Date Cleared
    2023-09-21

    (28 days)

    Product Code
    Regulation Number
    892.1200
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    Applicant Name (Manufacturer) :

    General Equipment for Medical Imaging, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CareMiBrain is dedicated brain PET scanner, and intended to obtain Position Emission Tomography (PET) inages of human brain to detect abnormal pattern of distribution of radioactivity after injection of a position emitting radiopharmaceutical. 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
    CareMiBrain is a small aperture Positron Emission Tomography (PET) scanner to image the distribution of injected positron emitting radiopharmaceuticals in the head of live humans in seating/reclined position. CareMiBrain is a PET (Positron Emission Tomography) dedicated to brain imaging. All elements of the system are integrated into a compact volume, containing the detection system, acquisition and control electronics and software. All elements of the system are integrated into a compact volume, containing the detection system, acquisition and control electronics and software. The scanner consists of 48 monolithic Lutetium OrthoSilicate (LYSO) crystals arranged in 3 rings of 16 modules each. Physical ring diameter is 260mm, with an effective 220 mm transaxial and 152 mm axial FOV. Crystal dimensions are 50x50x15mm (width x height x thickness). Crystals are coupled to a photosensor array of 12x12 silicon photo-multiplier (SiPM), 3x3 mm each. The detectors of the equipment are integrated in a circular housing with the appropriate dimensions so that the patient can insert the head. The software that integrates the equipment allows the acquisition, reconstruction and export of tomographic images of the brain, as well as to make a diagnosis of the state of the detectors.
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