# K180911: Visura Technologies TEECAD System

- Pathway: 510(k) (Traditional)
- Applicant: Visura Technologies, LLC
- Decided: Jun 20, 2018 after 75 days
- Product code: FDS (Gastroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K853585 (1986). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140595: Third Eye Panoramic Auxiliary Endoscopy System, Avantis Medical Systems, Inc. (2014) Summary page 4.

## Indications for use
The TEECAD System is intended to provide visualization during the placement of a Transesophageal Echocardiogram (TEE) probe in adults. Do not use this system for any purpose other than the intended use.

Source page: https://510kreport.com/device/K180911
Methodology: https://510kreport.com/methodology