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510(k) Data Aggregation

    K Number
    K032585
    Device Name
    TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM
    Manufacturer
    RON-TECH MEDICAL LTD.
    Date Cleared
    2004-01-09

    (141 days)

    Product Code
    HDC
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    RON-TECH MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SafeTChoice™ Transvaginal Ultrasound Probe Holder System is an accessory intended for use in conjunction with a transvaginal ultrasound transducer. The SafeTChoice™ Transvaginal Ultrasound Probe Holder System is intended to seize and hold the cervix and to hold and secure an ultrasound transducer in place, while performing sonographic procedures.
    Device Description
    The Safe TChoice™ Transvaginal Ultrasound Probe Holder System is an accessory used in conjunction with a transvaginal ultrasound transducer. The device is intended to hold and secure the ultrasound transducer in place on a uterine tenaculum, while performing the sonographic procedure. The configuration of the device allows the physician to manipulate the ultrasound transducer with one hand, thus freeing the other hand to perform the required procedure. The SafeTChoice™ Transvaginal Ultrasound Probe Holder System consists of a reusable uterine tenaculum with an adaptor bar, a sterile, disposable adaptor and a disposable probe connector.
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    K Number
    K992071
    Device Name
    TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE
    Manufacturer
    RON-TECH MEDICAL LTD.
    Date Cleared
    1999-08-27

    (70 days)

    Product Code
    HDC
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    RON-TECH MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Transvaginal Ultrasound Probe Holder device is an accessory used in conjunction with a transvaginal ultrasound transducer. The device is intended to seize and hold the cervix and to hold and secure an ultrasound transducer in place, while performing sonographic procedures.
    Device Description
    Transvaginal Ultrasound Probe Holder
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