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For detailed information regarding instructions for use, indications, contraindications, warnings, and precautions, please consult the device manual.
The CADDIE™ computer-assisted detection device is intended to assist the gastroenterologist in identifying suspected colorectal polyps only.
The gastroenterologist is responsible for reviewing CADDIE™ suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. The CADDIE™ device is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis or recommendations of treatment/course of action for patients.
The CADDIE™ computer-assisted detection device is limited for use with standard white-light endoscopy imaging only.
The EVIS X1™ endoscopy system is not designed for cardiac applications. Other combinations of equipment may cause ventricular fibrillation or seriously affect the cardiac function of the patient. Improper use of endoscopes may result in patient injury, infection, bleeding, and/or perforation. Complete indications, contraindications, warnings, and cautions are available in the Instructions for Use (IFU).
