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510(k) Data Aggregation

    K Number
    K163026
    Device Name
    Ultra/Phonic Scanning Gel
    Manufacturer
    Pharmaceutical Innovations Inc.
    Date Cleared
    2018-01-09

    (435 days)

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

    Pharmaceutical Innovations Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UltraPhonic® Scanning Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination. The product is indicated for prescription use only.
    Device Description
    Ultra/Phonic® Scanning Gel is an aqueous, non-sterile ultrasound conducting medium for use during non-invasive ultrasonic medical procedures. It is placed between the ultrasound transducer and the patient, eliminating air at the contact surface while providing lubrication. This provides an acoustic pathway between the transducer and the skin. This uninterrupted pathway allows the transducer to send sound waves which enter the body, and to receive echoes from tissues and structures without unexpected interference. When the echoes are received by the scanner, it analyzes them to determine how strong they are, and how long they took to be received after transmission. That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals. It is packaged in 4L Cubitainers, 5L Cubitainers, and 250 mL bottles.
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