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The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest.

The Perimeter OTIS™ 2.1 is an imaging tool for use on excised human tissue. The Perimeter OTIS™ 2.1 is based on optical coherence tomography (OCT) imaging, which is similar to ultrasound, but uses non-ionizing, low-power optical radiation to produce high resolution, sub-surface images of a tissue sample. Due to the extremely high velocity of light, optical echoes (reflected and backscattered light from the sample) cannot be measured directly using a photodetector. Instead, OCT devices use an interferometer to compare a reference beam of light to the backscattered light returning from the tissue sample. The features in an OCT image are created by changes in the optical properties (namely scattering, absorption, and index of refraction) of the sample. The Perimeter OTIS™ 2.1 collects and displays OCT images of human tissue with comparable image quality to the predicate Perimeter OTIS 2.0 System (K190404). Like its predicate, the Perimeter OTIS™ 2.1 has automated the OCT scanning of the specimen surface, standardizing the image collection process and facilitating image manipulation for review and annotation. OTIS 2.1 allows for the concurrent image review and acquisition.