# K111997: IMAGE1 GI Ccu Model 22203020-114

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Apr 6, 2012 after 268 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- 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: 2 generations back to K944620 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003325: Ksi's New Camera Architecture (Nca) Video Imaging System, Karl Storz Imaging, Inc. (2001) Summary page 1.
- K102466: Fujinon Epx-4440HD Digital Video Processor, Fujinon, Inc. (2011) Summary page 1.

## Indications for use
The Imagel GI CCU is to be used in conjunction with a light source and endoscope by physician/endoscopist to provide optical visualization via a video monitor for endoscopic observation and image recording during diagnostic and therapeutic procedures of the upper/lower digestive tract.

Source page: https://510kreport.com/device/K111997
Methodology: https://510kreport.com/methodology