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510(k) Data Aggregation

    K Number
    K112293
    Device Name
    HTS EXTREMITY COIL, HTS SURFACE COIL
    Manufacturer
    TIME MEDICAL SYSTEMS INC
    Date Cleared
    2011-09-30

    (51 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    TIME MEDICAL SYSTEMS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HTS Surface Coil is used to image peripheral anatomies, such as, wrist, ankle, Temporo-mandibular Joints (TMJ), Eye, finger and other parts of the body, close to the surface of skin. It is compatible to be used with Time Medical's 0.35T PICA Whole Body MRI System. HTS Extremity Coil is predominantly used for imaging anatomies, such as, knee, ankle, and wrist. It is compatible to be used with Time Medical's 0.35T PICA Whole Body MRI System.
    Device Description
    HTS Surface Coil (TM-HTS-SF001-0R35), HTS Extremity Coil (TM-HTS-KN001-0R35). Single-Channel, Receive-Only, LN2 (Liquid Nitrogen) Cooling liquid. HTS Surface Coil is Single Channel surface coil. HTS Extremity Coil is Single Channel Volume coil. Material: ABS.
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