# K990154: Karl Storz Direct Coupled Interface (Dci 5) Camera System

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Imaging, Inc.
- Decided: Jun 1, 1999 after 133 days
- Product code: FWF (Camera, Television, Endoscopic, Without Audio)
- Device class: 1
- Regulation: 21 CFR 878.4160
- 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 K883943 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973252: Karl Storz Direct Coupled Camera Head, Karl Storz Imaging, Inc. (1997) Summary page 2.
- K950974: Karl Storz Endovision Digivideo (Digital Image Processor) Accessory for Color Television Camera Used in Endoscopic Procs, Karl Storz Imaging, Inc. (1995) Summary page 2.
- K940283: Karl Storz Endovision Urocam/Hysterocam, Medical Concepts, Inc. (1994) Summary page 2.

## Indications for use
The Karl Storz Imaging (KSI) Direct Coupled Interface (DCI 5) Camera System is a color, television camera head with integrated light source cable, and separate video processor. The camera system is suitable for use with any KST DCI rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope by directly pressing the endoscope onto the front of the DCI 5 camera head until it locks into place. The endoscopic image can be displayed on any standard operating room video monitor.

Source page: https://510kreport.com/device/K990154
Methodology: https://510kreport.com/methodology