# K003325: Ksi's New Camera Architecture (Nca) Video Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Imaging, Inc.
- Decided: Apr 27, 2001 after 185 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.
56 later devices descend from it; 3 cite it directly.
1 of 57 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K131369: Flexible Video-Uretero-Renoscope System (2013), 53 descendants of its own
- K172098: Medical Video Endoscope System (2017), 23 descendants of its own
- K141250: Flexible Video-Uretero-Renoscope System (2014), 11 descendants of its own
- K180367: Ureterorenoscope System (2018), 9 descendants of its own
- K142556: Flexible Video-Uretero-Choledochoscope System (2014), 7 descendants of its own

## Indications for use
The Karl Storz Imaging (KSI) New Camera Architecture (NCA) Video Imaging System is a color, television camera system which can be used with rigid or flexible endoscopes, such as sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope. Any compatible NCA camera head may be used with the NCA KSI Camera Control Unit (CCU). The endoscopic image can be displayed on any standard operating room video monitor. All standard endoscopic light sources may be used with New Camera Architecture (NCA) camera heads. Both single chip and three chip camera heads will be available in NTSC and PAL configurations.

Source page: https://510kreport.com/device/K003325
Methodology: https://510kreport.com/methodology