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510(k) Data Aggregation

    K Number
    K222258
    Device Name
    Combined High Frequency X-ray Source
    Date Cleared
    2022-11-01

    (97 days)

    Product Code
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    Suzhou Powersite Electric Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Combined High Frequency X-ray Source is intended for use by a qualified/trained technician on both adult and pediatric subjects for body extremities and cervical spine exclusively. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
    Device Description
    PSM-PD series combined high frequency X-ray source is an advanced high frequency X-ray source, which is mainly composed of shell case, control panel mounting assembly, DCDC riser mounting assembly, power panel mounting assembly, ESU energy storage capacitor mounting assembly, high voltage TANK, collimator, Lithium battery. The product is small in size, light in weight and high in power density, which can meet the needs of outdoor portability. At the same time, we provide battery-powered solutions to meet customers' diversified demands for product functions.
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