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The Prostate Mechanical Imager (PMI) is indicated for the production of an elasticity image of the prostate as an aid in documenting prostate abnormalities that were previously identified by digital rectal examination (DRE). The device utilizes a transrectal probe with pressure sensor arrays and a motion tracking system and provides real-time elasticity images of the prostate. This device is limited to use as a documentation tool and therefore is not to be used for cancer diagnosis or for any other diagnostic purpose. This device is only to be used to image and document an abnormality that was already identified by DRE. Clinical management decisions are not to be made on the basis of information from the PMI device, but rather on the basis of the DRE. If there is disagreement between the DRE and the recorded image produced by the device, patient management decisions are to be based on the DRE and other available clinical and diagnostic information (e.g., prostate-specific antigen (PSA) levels) in accordance with standard medical practice.

The Prostate Mechanical Imager (PMI) is an electronic palpation device that is meant to mimic the digital rectal examination (DRE) by generating images of pressure patterns of the palpated prostate. The information provided by the device is characterized as being similar in nature to the information obtained from a standard DRE (i.e., determination of regions of relative tissue hardness within the prostate) with the utility being that the results are visually displayed and can be electronically saved, transmitted, and/or printed out for documenting in patient's medical records.