> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Clears Perimeter Optical Coherence Tomography System
- URL: https://www.fdaweb.com/fda-clears-perimeter-optical-coherence-tomography-system/
- Published: 2016-05-24T12:00:00.000Z
- Updated: 2026-09-14T21:05:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135757

FDA has cleared a Perimeter Medical Imaging 510(k) for its OTIS 1.0 Optical Coherence Tomography System. The company says the device provides “high-resolution, real-time imaging of the periphery of excised tissue, enabling clinicians to visualize sub-surface structures up to 2 mm below the surface. These sub-surface structures would otherwise not be evident until days – and often weeks – later when conventional histology slides are available for review.”OTIS is indicated for use as an imaging tool in evaluating excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, Perimeter says. “Previously-cleared devices required the clinician-user to move his/her hand to collect ‘point-by-point’ images, increasing operator workload and generating images from only a small number of points on the specimen,” it says. “The OTIS leverages Perimeter’s proprietary Wide-Field Optical Coherence Tomography Imaging technique to overcome this limitation, leading to rapid, intuitive imaging of the entire specimen.”