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510(k) Data Aggregation

    K Number
    K042619
    Device Name
    ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT
    Manufacturer
    SONOTECH, INC.
    Date Cleared
    2004-11-05

    (42 days)

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

    SONOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UltraBio, as an in vivo biocompatible and bioexcretable sterile couplant, is intended to replace sterilized transcutaneous scanning gels that are not in vivo biocompatible or in vivo bioeliminated in surgical procedures, biopsies and similar sterile applications. UltraBio will be used to couple sound waves between the patient and medical imaging electronic transducers during transcutaneous and intracavitary medical diagnostic ultrasound imaging procedures. It will be used with transcutaneous and intracavity ultrasound imaging. UltraBio is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or fluid alone or in combination with a latex sheath where sterility and bioelimination are required.
    Device Description
    UltraBio - In Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant
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    K Number
    K033178
    Device Name
    ULTRABIO
    Manufacturer
    SONOTECH, INC.
    Date Cleared
    2004-08-04

    (308 days)

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

    SONOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UltraBio, as an in vivo biocompatible and bioexcretable sterile couplant, is intended to replace UltraBlo, as an in Wo bloompatible and brookers on in vivo bioshested on vivo biosxcretable, but sterilized transculaneous sounting gold transmilar sterile applications. UltraBio will be used to couple sound waves between the patient and medical imaging electronic UltraBlo will be used to couple sound waves between in the material consisted on the consective transducers during intraoperative and intraction in and aspiration, intraoperative ultrasound imaging, and intracavity ultrasound imaging. UltraBio is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound Ultration is unlift use packaged, sichiles and interess for fluid alone or in combination with a latex, and procedures that canently use an undaound beaping get in the biocompatibility and bioelimination are required.
    Device Description
    Not Found
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    K Number
    K031222
    Device Name
    SCANLUBE
    Manufacturer
    SONOTECH, INC.
    Date Cleared
    2003-07-23

    (97 days)

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

    SONOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ScanLube is an in vivo biocompatible and biodegradable sterile ultrasound couplant that will be used in coniunction with hydrogel pads, such as Sonotech's ScanTac Pad, during medical diagnostic ultrasound imaging to couple ultrasound waves between the patient and medical imaging electronics. ScanLube converts an adhesive hydrogel surface into a lubricous surface by hydrogen bonding with the ScanTac Pad, which then facilitates scanning with an ultrasound transducer. ScanLube is intended for use with the ScanTac Strip and ScanTac Pad in conjunction with transcutaneous ultrasound image guided biopsy and aspiration, and within a protective sheath (probe cover) for intraoperative and endocavity ultrasound imaging. ScanLube, when swabbed or similarly applied to the exposed surface of a hydrogel strip, such as the ScanTac Strip, when attached to the face of a transducer, converts the exposed hydrogel adhesive surface to lubricous, thus enabling the easy insertion of the hydrogel covered transducer into a transducer cover or sheath, or for scanning the patient using direct contact of the lubricous hydrogel surface. ScanLube is unit dose packaged, sterilized and intended for use as a couplant and lubricant in all diagnostic ultrasound procedures which currently use an ultrasound coupling gel or fluid alone or in combination with a latex, polyurethane or polyethylene transducer cover where sterility and in vivo biocompatibility are required. ScanLube may be used to lubricate the exterior surface of endocavity transducer sheaths or covers prior to insertion into the vagina or rectum. In this application, ScanLube serves both as an ultrasound couplant and instrument lubricant.
    Device Description
    Not Found
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    K Number
    K031894
    Device Name
    SCANTEC PAD
    Manufacturer
    SONOTECH, INC.
    Date Cleared
    2003-07-18

    (29 days)

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

    SONOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The biocompatible ScanTac Membrane or Pad will be used during medical diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics by being affixed to the active element of the transducer. The pad is biocompatible, sterile, and, being solid, leaves no residue. It will be used for transcutaneous ultrasound imaging over surgical wounds, during transcutaneous biopsy and to enhance acoustic coupling to difficult geometries. The pad is sufficiently adherent to remain in place during the procedure. The pad is placed onto the patient, and is a hydrogel. The exposed side of the hydrogel pad will be rendered lubricous with an application of ultrasound coupling sterile fluid, including ScanLube™, water or saline.
    Device Description
    Not Found
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    K Number
    K013701
    Device Name
    ENDO-GLIDE
    Manufacturer
    SONOTECH, INC.
    Date Cleared
    2002-02-04

    (88 days)

    Product Code
    GCJ, ITX
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    SONOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lubricate the insertion and passage of imaging devices and surgical instrumentation, such as endoscopes, ultrasound transducers, cransesponias instrumentation, Such as Chaoseoped, catheters and surgical instrumentation.
    Device Description
    Endo-Glide™ is a lubricant that is biocompatible with all hollow viscera, is in vivo biocompatible with tissue and body fluids, is in vivo biodegradable and is recognized as safe for oral administration'. Endo-Glide is an excellent film former, requiring a thin coating to adequately lubricate an instrument, thus using less material. A thin film of Endo-Glide has excellent adherence and will not "snowplow" when inserted into an orifice, which can create dry spots on an instrument, and most particularly on an endoscope. Endo-Glide will be offered in sterile and non-sterile packaging for endoscopic, transurethral and surgical instrumentation lubrication.
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    K Number
    K013170
    Device Name
    SCANTAC MEMBRANE OR SCANTAC STRIP
    Manufacturer
    SONOTECH, INC.
    Date Cleared
    2001-11-13

    (50 days)

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

    SONOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The biocompatible ScanTac Strips will be used in diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics. ScanTac Strips are biocompatible, sterile, and, being solid, leave no residue. They are single use and disposable. ScanTac Strips are intended for use in sterile fields substituting for an ultrasound coupling gel or fluid, as currently used, in combination with a latex, polyurethane, polypropylene or other polymeric protective transducer cover. The ScanTac Membrane is used for transcutaneous ultrasound imaging over wounds and to enhance imaging contact over difficult geometries. The ScanTac Membrane has a backing on one side that is removed prior to transcutaneous scanning. The Membrane is placed onto the patient, and is sufficiently adherent to remain in place during the scan due to the adhesive nature of the hydrogel. Either water or ultrasound scanning gel is used on the other side of the Membrane between the transducer and the Membrane.
    Device Description
    ScanTacTM Membrane and ScanTac™ Strip
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    K Number
    K984562
    Device Name
    VIVOSONIC
    Manufacturer
    SONOTECH, INC.
    Date Cleared
    1999-06-08

    (167 days)

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

    SONOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used during invasive medical diagnostic ultrasound imaging to couple sound waves between the patient and the medical imaging electronics, and to lubricate the insertion and passage of imaging devices. Used in conjunction with transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, endocavity ultrasound imaging and ophthalmic ultrasound imaging. Intended for use in all diagnostic ultrasound procedures which currently use an ultrasound coupling gel or fluid alone or in combination with a latex, polyurethane or polyethylene transducer cover where sterility and in vivo biocompatibility are required.
    Device Description
    VivoSonic - In Vivo Biocompatible Sterile Ultrasound Imaging Couplant
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    K Number
    K983691
    Device Name
    SCANFLEX SOLID COUPLANT MEMBRANE
    Manufacturer
    SONOTECH, INC.
    Date Cleared
    1999-05-05

    (197 days)

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

    SONOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ScanFlex Solid Couplant Membranes is intended for use during transcutaneous (external) and invasive (intraoperative and/or endocavity) medical diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics. ScanFlex Solid Couplant Membranes are intended for use in sterile fields, including intraoperative, endocavity or transcutaneous ultrasound imaging procedures which currently use an ultrasound coupling gel or fluid in combination with a latex, polyurethane or polypropylene protective transducer cover. ScanFlex is intended for use in non-sterile transcutaneous applications where a solid couplant would be advantageous.
    Device Description
    ScanFlex Solid Couplant Membrane
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    K Number
    K983985
    Device Name
    HYBRISONIC SHEATH
    Manufacturer
    SONOTECH, INC.
    Date Cleared
    1999-02-25

    (108 days)

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

    SONOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Couplant: HybriSonic Sheaths will be used during invasive medical diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics, intended for use in sterile and non-sterile fields, including intraoperative, endocavity or transcutaneous ultrasound imaging procedures when used alone or in combination with an ultrasound coupling gel or fluid alone or in combination with a latex, polypropylene protective transducer cover. The Combination are intended to be used without additional lubrication for typically ultrasound such as ultrasound guided biopsy and aspiration. Microbial barrier: HybriSonic Sheaths are also intended for use as ultrasound transducer Microbial barriers that are in vivo biocompatible with tissue and body fluids and leave no residue with the transducer, are single use and disposable. Device lubricant: In addition to coupling ultrasound, the HybriSonic Sheath is intended for use as a device lubricant and microbial barrier during transcutaneous ultrasound exams and with ultrasound imaging and transcutaneous ultrasound guided biopsy or aspiration.
    Device Description
    HybriSonic Sheath
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    K Number
    K981028
    Device Name
    ULTRA IMAGE AND ULTRA SCAN
    Manufacturer
    SONOTECH, INC.
    Date Cleared
    1998-08-21

    (155 days)

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

    SONOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sono Image and Ultra Glide are coupling gels and will be used in conjunction with ultrasound transducers during medical diagnostic ultrasound to couple sound waves into the patient's body. Sono Image is a high viscosity scanning gel suitable for echocardiography, vascular sonography and general ultrasound scanning procedures. Ultra Glide is a low viscosity scanning gel suitable for abdominal, OB/GYN and general ultrasound scanning procedures.
    Device Description
    Sono Image and Ultra Glide are medical diagnostic ultrasound scanning gels that transmit sound waves into the body through the skin and whose formulas are identical except for the polymer (thickener) content. Sono Image and Ultra Glide do not contain silicon, mineral oil, surfactants or any chemicals which are considered harmful to ultrasound transducer material (see Sono Image and Ultra Glide product formulation).
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