Address:359 Eastern Avenue,Toronto Ontario,CA
Device Description : The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imag 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, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest. Perimeter’s OTIS 2.1 cart assembly encloses an OCT-based imaging system and has a touchscreen monitor.
Device Class :
Duns Number: 204112346
Premarket Exempt : No
Prescription Use : Yes
Device Description : The OTIS 2.1 system includes a single-use specimen container, the Consumable Set The OTIS 2.1 system includes a single-use specimen container, the Consumable Set, that facilitates tissue imaging. The consumable set consists of a Specimen Tray and Specimen Lid. The Specimen Tray engages with the device to initiate scanning and the Specimen Lid facilitates engaging vacuum to enable vacuum assisted specimen positioning during image acquisition.
Device Class :
Duns Number: 204112346
Premarket Exempt : No
Prescription Use : Yes
Device Description : The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imag 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, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest. Perimeter’s OTIS 2.1 cart assembly encloses an OCT-based imaging system and has a touchscreen monitor.
Device Class :
Duns Number: 204112346
Premarket Exempt : No
Prescription Use : Yes