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FDA-cleared K203578

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System

Perimeter Medical Imaging AI, Inc.

Authorized purpose: OTIS 2.1 is indicated as an imaging tool for evaluating 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.

Modality
Optical Coherence Tomography
Anatomy
Excised human tissue microstructure
Decision
2021-02-25