The iBreastExam Device is intended to produce a surface pressure map of the breast as an aid in identifying and documenting breast lesions. The iBreastExam Device is intended for use by qualified healthcare professionals trained in its use.
A portable electrically-powered assembly of devices designed to electronically measure and map data regarding breast lesions/masses with regard to shape, size, location, consistency/relative hardness during a clinical breast examination (CBE). It is typically used by physicians/clinical practitioners that perform CBE during breast cancer screening and evaluation of suspected breast masses. It typically consists of a hand-held applicator (tactile receptor containing pressure transducers), a portable computer, application software, and a calibrator. Scanning is performed over the entire breast or an area of interest and is typically displayed as a colour map differentiating the tissues.
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