Study Comparing Blue Light Imaging (BLI) With Flexible Spectral-Imaging Color Enhancement (FICE)

A Concurrence Study of Diagnostic Visualization Comparing Blue Light Imaging (BLI) With Flexible Spectral-Imaging Color Enhancement (FICE)

The study is intended to demonstrate substantial equivalence of visualization using BLI to the predicate device, FICE, so as to support the addition of BLI as an adjunct to white light imaging in the company's video processor.

This clinical study will consist of acquisition of images, followed by a reader study.

Inclusion Criteria:

• Referred for clinically indicated gastrointestinal diagnostic endoscopy
• Ability to understand the requirements of the study, to provide written informed consent and to comply with the study protocol
• Ability to understand and provide written authorization for the use and disclosure of protected health information (PHI) per the Health Insurance Portability and Accountability Act (HIPAA) privacy ruling.

Exclusion Criteria:

• Under the age of 21 years
• Is an inmate (see US Code of Federal Regulations 45 C.F.R. 46.306)