Search Results

The OTIS 2.0 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™ 2.0 is an imaging tool for use on excised human tissue. The Perimeter OTIS™ 2.0 is based on optical coherence tomography (OCT) imaging, and it 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™ 2.0 collects and displays OCT images of human tissue with comparable image quality to other previously 510(k)-cleared OCT imaging systems and, specifically, the predicate Perimeter OTIS 1B System (K171560). Like its predicate, the Perimeter OTIS™ 2.0 has automated the OCT scanning of the specimen surface, standardizing the image collection process. The Perimeter OTIS™ 2.0 includes a white light image (photograph) of the specimen, to assist the clinician in viewing the OCT images with a reference to the photograph and the OCT image scan position. The Perimeter OTIS™ 2.0 also includes user interface options, such as the ability to "scroll" through the OCT images, across a specimen's surface, as well as to zoom and pan in more closely to examine areas of interest, as desired.

The OTIS 1B Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest.

The Perimeter OTIS 1B 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 1B collects and displays OCT images of human tissue with comparable image quality to other previously 510(k)-cleared OCT imaging systems and, specifically, the Perimeter OTIS 1.0 System (K160240). Like its predicate, the Perimeter OTIS 1B has automated the OCT scanning of the specimen surface, standardizing the image collection process. The Perimeter OTIS 1B includes a white light image (e.g., photograph) of the specimen, to assist the clinician in viewing the OCT images with a reference to the white light image and the OCT image scan position. The Perimeter OTIS 1B also includes user interface options, such as the ability to "scroll" through the OCT images, across a specimen's surface, as well as to zoom and pan in more closely to examine areas of interest, as desired.

The OTIS 1.0 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-section, real-time depth visualization.

The Perimeter Optical Tissue Imaging System (OTIS) 1.0 is an imaging tool for use on excised human tissue. The Perimeter OTIS 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 collects and displays OCT images of human tissue with comparable image quality to other previously 510(k)-cleared OCT imaging systems. However, rather than requiring the clinician to move his/her hand to collect "point-by-point" images, the Perimeter OTIS has automated the OCT scanning of the specimen surface, standardizing the image collection process. The Perimeter OTIS also includes a white light image (e.g., photograph) of the specimen, to assist the clinician in viewing the OCT images with a reference to the white light image and the OCT image scan position. In addition, the Perimeter OTIS includes user interface options, such as the ability to "scroll" through the OCT images, across a specimen's surface, as well as to zoom and pan in more closely to examine areas of interest, as desired.