# K131953: IMAGE1 Spies

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Dec 20, 2013 after 176 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- 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.
10 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070716: Image 1 Video Imaging System with Optional Insufflators Control, KARL STORZ Endoscopy-America, Inc. (2007) Summary page 2.
- K102466: Fujinon Epx-4440HD Digital Video Processor, Fujinon, Inc. (2011) Summary page 2.

## Most influential descendants
- 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
- K190648: Pusen Eview Medical Video Endoscope Image Processor (2019), 1 descendant of its own
- K254242: KARL STORZ ICG Imaging System with RUBINA® Lens (2026), 0 descendants of its own

## Recalls of this device
- Jun 20, 2016 · Class II · Z-2134-2016: Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinocope and an electro-surgery generator (ESG).

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

Source page: https://510kreport.com/device/K131953
Methodology: https://510kreport.com/methodology