# K070716: Image 1 Video Imaging System with Optional Insufflators Control

- Pathway: 510(k) (Special)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: May 31, 2007 after 78 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
No predicates in its family tree.
16 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K131953: IMAGE1 Spies (2013), 10 descendants of its own
- K160044: Image1 SPIES System (2016), 6 descendants of its own
- K201135: Image1 S CCU, Image1 S 4U Camera Head (2020), 4 descendants of its own
- K233333: KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit (2023), 2 descendants of its own
- K182696: Telepack X LED (2018), 2 descendants of its own

## Indications for use
The Karl Storz Image 1® Video Imaging System with optional insufflators control allows remote control of Karl Storz insufflators by image 1® camera head control buttons. The Karl Storz Image 1® Video Imaging System is a color video camera system which can be used as an endoscopic accessory with rigid or flexible endoscopes. The camera head is directly coupled to the endoscope. Any compatible Image 1® camera head may be used with the Image 1® Karl Storz Camera Control units (CCU). The endoscopic image can be displayed on any standard operating room video monitor and all standard endoscopic light sources may be used with the Image 1® camera head.

Source page: https://510kreport.com/device/K070716
Methodology: https://510kreport.com/methodology