# K160044: Image1 SPIES System

- Pathway: 510(k) (Special)
- Applicant: Karl Storz Endoscopy America, Inc.
- Decided: Feb 1, 2016 after 24 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: 3 generations back to K944620 (1995). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131953: IMAGE1 Spies, KARL STORZ Endoscopy-America, Inc. (2013) Summary page 4.

## Most influential descendants
- 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
- K254242: KARL STORZ ICG Imaging System with RUBINA® Lens (2026), 0 descendants of its own
- K253972: IMAGE1 (TC400US); X-to-4U Adapter (TC040) (2026), 0 descendants of its own
- K250462: UL UHD-Clear View 4K Camera System (UL-3Chip 4K) (2025), 0 descendants of its own

## Indications for use
The IMAGET! SPIES is a camera control unit (CCU) for use with camera heads or video endoscopes for the visualization, image recording and documentation during general endoscopic and microscopic procedures.

Source page: https://510kreport.com/device/K160044
Methodology: https://510kreport.com/methodology