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510(k) Data Aggregation

    K Number
    K241266
    Device Name
    Imaging system of positron emission and X-ray computed tomography (DigitMI 930)
    Manufacturer
    RAYSOLUTION Healthcare Co., Ltd
    Date Cleared
    2025-01-27

    (266 days)

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

    RAYSOLUTION Healthcare Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Imaging system of positron emission and X-ray computed tomography is a PET/CT system for producing attenuation corrected PET images. It is intended to be used by qualified health care professionals for imaging the distribution and localization of any positron-emitting radiopharmaceutical in a patient, for the assessment of metabolic (molecular) and physiologic function in patients, with a wide range of sizes and extent of disease, of all ages. Imaging system of positron emission and X-ray computed tomography is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The images produced by the system may be used by physicians to aid in radiotherapy treatment planning, therapy guidance and monitoring, and in interventional radiology procedures. The images may also be used for precise functional and anatomical mapping (localization, registration, and fusion). When used with radiopharmaceuticals approved by the regulatory authority in the country of use, the raw and image data is an aid in; detection, localization, diagnosis, staging, restaging, monitoring, and/or follow up, of abnormalities, lesions, tumors, inflammation, infection, organ function, disorders, and/or disease, such as, but not limited to, those in oncology, cardiology, and neurology. Examples of which are: Cardiology: - Cardiovascular disease - Myocardial perfusion - Myocardial viability - Cardiac inflammation - Coronary artery disease Neurology: - Epilepsy - Dementia, such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia. and frontotemporal dementia. - Movement disorders, such as Parkinson's and Huntington's disease - Tumors - Inflammation - Cerebrovascular disease such as acute stroke, chronic and acute ischemia - Traumatic Brain Injury (TBI) Oncology/Cancer: - Non-Small Cell Lung Cancer - Small Cell Lung Cancer - Breast Cancer - Prostate Cancer - Hodgkin disease - Non-Hodakin Ivmphoma - Colorectal Cancer - Melanoma Imaging system of positron emission and X-ray computed tomography is also intended for standalone, diagnostic CT imaging in accordance with the stand-alone CT system's cleared indications for use.
    Device Description
    The Imaging system of positron emission and X-ray computed tomography (model: DigitMI 930) is a PET/CT diagnostic imaging system combining a Positron Emission Tomography (PET) System and a Computed Tomography (CT) System. The Imaging system of positron emission and X-ray computed tomography (model: DigitMI 930) consists of a scanning system, power distribution unit, table system, data processing system, and console system. The PET part consists of a 72 ring LYSO detector, while the CT part has 64 physical rows of detectors.
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