indications for use

Niris Imaging System: An imaging tool for the evaluation of tissue microstructure1 by providing two-dimensional, cross-sectional, real-time depth visualization.

Niris Probe Sheath: The Niris Probe Sheath is a sterile, single-use, protective sheath that is used as an accessory with the Imalux Niris Imaging System. The Niris Probe Sheath is intended to serve as a microbial barrier between the probe and the patient’s tissue, helping to prevent the transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the probe.

1 Tissue microstructure is defined as the spatial distribution of (histo)morphological features and elements at a spatial scale between 10 micrometers to several millimeters.

 

The information provided on this website is for the purpose of educating potential users about the OCT technology.  Pictures contained on this website are for demonstration purposes only and should not be construed to accurately depict the body part, condition, or disease described.  Nothing contained on this website is intended to be instructional for medical diagnosis or treatment.  The information contained herein should not be considered complete, or take the place of thoroughly reading all inserts and labels pertaining to and included with the OCT technology.

Imalux shall not be liable for any improper use of the OCT technology and makes no representations or warranties as to the OCT technology’s efficacy, except as described in the labeling and inserts included with the product.  Imalux makes no representations or warranties as to the use of OCT technology in the event that the user attempts to service or repair the machine without using a technician certified by Imalux or uses any accessories other than those recommended by Imalux.

Caution: Federal law restricts this device to sale by or on the order of a physician.

 

 
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