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The EVIS 140 System is specifically designed for endoscopic diagnosis, treatment, and photo and video documentation in combination with Olympus endoscopes, various accessories and ancillary equipment within the upper and lower digestive tract including esophagus, stomach, pancreatic duct, biliary duct, duodenum, small intestine, rectum and colon.

Olympus EVIS 140 System, associated endoscope, and ancillary equipment and endoscopic accessories

This document is a 510(k) summary for the Olympus EVIS 140 Video Endoscopy System, submitted in 1996. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Device Identification: Name, common name, classification name, predicate devices.
• Contact Information: For the submitter.
• Intended Use: Highlighting its use for endoscopic diagnosis, treatment, and documentation in various parts of the digestive tract.
• Claim of Substantial Equivalence: Stating that its intended use is identical to a previously cleared device (Olympus EVS System) and therefore "does not raise any questions regarding the safety of the subject device."

Therefore, I cannot provide the requested table and study details based on the provided text. The prompt asks for information that is simply not present in this 510(k) summary. This type of regulatory submission from 1996 usually relies on demonstrating substantial equivalence to a predicate device rather than providing extensive performance studies against specific acceptance criteria in the way more modern AI/software device submissions do.

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