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510(k) Data Aggregation

    K Number
    K082893
    Device Name
    PRAGER SHELL
    Manufacturer
    Date Cleared
    2008-12-05

    (66 days)

    Product Code
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Prager Shell® is a plastic device intended to provide a water path between an ultrasound transducer and the eye for A-scan biometry of the eye.
    Device Description
    The shell is a cylinder with an open top and open bottom,. The open bottom end is contoured at the rim to conform to the curvature of the eye. The ultrasonic transducer is placed in the Prager Shell® from above. Once placed on the eye the shell is filled with balanced salt solution (BSS) and the probe distal end is immersed in the BSS. It is not sold sterile and is reusable. Tubing kits are available to connect the shell to the BSS source. These kits are distributed by ESI but not manufactured by it.
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    K Number
    K080119
    Device Name
    CLEARSCAN
    Manufacturer
    Date Cleared
    2008-02-21

    (35 days)

    Product Code
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ClearScan™ ultrasound probe cover is intended to be used as a sterile, single-use protective cover with fluid coupling between the eye or skin and an ultrasonic transducer. The ClearScan™ ultrasound probe cover is indicated when it is necessary to have a sterile, single-use protective sheath with fluid coupling between the examined sufface and an ultrasonic transducer.
    Device Description
    The ClearScan™ ultrasound probe cover is intended to be used as a sterile, single-use protective cover with fluid coupling between the examined surface and an ultrasonic transducer. The device provides a microbial barrier between the probe and the patient's tissue, helping to prevent the transfer of microorganisms, body fluids and particulate material to the patient and healthcare personnel. It provides a water path between the trausducer and the surface scanned. The ClearScan™ material that contacts the eye or skin tissue is made of a soft pliable plastic film. The JlearScan is a sealable plastic sac that encloses the transducer and holds water to make the water path for scanning. The ClearScan is made of a biologically-compatible, non-latex membrane. It has a special collar that permits it to be sealed around the body of the transducer.
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