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510(k) Data Aggregation

    K Number
    K242499
    Device Name
    Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))
    Manufacturer
    Shenzhen SONTU Medical Imaging Equipment Co., Ltd.
    Date Cleared
    2025-01-06

    (137 days)

    Product Code
    KPR, MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen SONTU Medical Imaging Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Digital radiography X-ray system is used in hospitals, clinics, and medical practices. The Digital radiography X-ray system enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. It is not intended for mammographic applications. The Digital radiography X-ray system uses digital detectors for generating diagnostic images by converting X-rays into image signals.
    Device Description
    The Digital Radiography X-ray System is a radiography X-ray system. It is designed as a modular system with components such as a ceiling suspension with an X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless, and fixed integrated detectors that may be combined into different configurations to meet specific customer needs. Software is of Basic level of concern, which is also based on a predicate device.
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