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Found 13 results
510(k) Data Aggregation
K Number
K042619Device 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
892.1570Why 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
K033178Device Name
ULTRABIO
Manufacturer
SONOTECH, INC.
Date Cleared
2004-08-04
(308 days)
Product Code
MUI
Regulation Number
892.1570Why 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
K031222Device Name
SCANLUBE
Manufacturer
SONOTECH, INC.
Date Cleared
2003-07-23
(97 days)
Product Code
MUI
Regulation Number
892.1570Why 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
K031894Device Name
SCANTEC PAD
Manufacturer
SONOTECH, INC.
Date Cleared
2003-07-18
(29 days)
Product Code
MUI
Regulation Number
892.1570Why 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
K013701Device Name
ENDO-GLIDE
Manufacturer
SONOTECH, INC.
Date Cleared
2002-02-04
(88 days)
Product Code
GCJ, ITX
Regulation Number
876.1500Why 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
K013170Device Name
SCANTAC MEMBRANE OR SCANTAC STRIP
Manufacturer
SONOTECH, INC.
Date Cleared
2001-11-13
(50 days)
Product Code
ITX
Regulation Number
892.1570Why 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
K984562Device Name
VIVOSONIC
Manufacturer
SONOTECH, INC.
Date Cleared
1999-06-08
(167 days)
Product Code
ITX
Regulation Number
892.1570Why 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
K983691Device Name
SCANFLEX SOLID COUPLANT MEMBRANE
Manufacturer
SONOTECH, INC.
Date Cleared
1999-05-05
(197 days)
Product Code
ITX
Regulation Number
892.1570Why 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
K983985Device Name
HYBRISONIC SHEATH
Manufacturer
SONOTECH, INC.
Date Cleared
1999-02-25
(108 days)
Product Code
ITX
Regulation Number
892.1570Why 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
K981028Device Name
ULTRA IMAGE AND ULTRA SCAN
Manufacturer
SONOTECH, INC.
Date Cleared
1998-08-21
(155 days)
Product Code
ITX
Regulation Number
892.1570Why 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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