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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.

ScanFlex Solid Couplant Membrane

The provided text is an FDA 510(k) clearance letter and an Indications for Use statement for the "ScanFlex Solid Couplant Membrane." It addresses regulatory classification and intended use but does not contain information about device performance, acceptance criteria, or details of a study that proves the device meets such criteria.

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To answer your request, I would need a different document, such as a summary of safety and effectiveness, or the full 510(k) submission, which would typically describe the testing and performance of the device.

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