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510(k) Data Aggregation

    K Number
    K231420
    Device Name
    Aura 10 PET/CT
    Manufacturer
    Date Cleared
    2023-08-10

    (86 days)

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

    XEOS Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AURA 10 PET/CT system is a cabinet diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The AURA 10 PET/CT system images harvested specimens from various anatomical regions in order to provide rapid verfication that the correct tissue has been excised during the surgical procedure. Images can be obtained as CT only, or a combination of both by surgeon's discretion. The AURA 10 cabinet PET/CT system provides an image of extent and degree of intensity radiopharmaceutical uptake in the specimen by PET and the anatomical information by CT, which will help the surgeon with further patient management. The AURA 10 PET/CT system is not validated for margin detection.
    Device Description
    The AURA 10 PET/CT is a mobile, vertical-bore PET/CT system with a Field of View (FOV) suitable for small pathology specimens. It is intended to be used in both the operating room (OR) as well as the pathology department to image pathology specimens from various anatomical regions in order to provide rapid pathology imaging. The AURA 10 PET/CT is intended to image pathology specimens for a wide range of patient types, sizes, and extent of diseases. It is designed as a mobile cart so that it is easily portable by one person and can be moved to different surgical suites or between departments as needed.
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