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510(k) Data Aggregation

    K Number
    K052541
    Device Name
    MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM
    Date Cleared
    2005-11-03

    (49 days)

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

    AVANT MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
    Device Description
    HF50-R High Frequency Special Radiography System can be applied in hospitals of different levels to meet the requirements of radiographic diagnosis. The system is complete, consisting of a 50kw generator, X-Ray tube assembly, collimator, tube mounting hardware, and an x-ray table. This product is applicable to clinical diagnostic radiography in all hospitals large or small. It has functions such as ionization chamber automatic exposure control (AEC), automatic radiography (APR), general radiography etc. It is applicable to the radiography of various parts of human body. It is a dedicated radiographic device for gastro-intestinal tract and the like. The technical characteristics parallels to that in the world in the late '90s of last century. It can also be used in scientific research and education of medical scientific research institutes and medical colleges. Power supply requirements: three phase: 380V, 50/60Hz; single phase: 220V, 50/60 Hz; fluctuation range for voltage: 10%; capacity: 55kVA. Environment requirements: temperature: 15-35C; relative humidity: 45-75%. Atmospheric pressure: 80.0kPa-106.0kPa.
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