# K212695: KARL STORZ ICG Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy America
- Decided: Nov 15, 2021 after 82 days
- Product code: OWN (Confocal Optical Imaging)
- 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: 19 generations back to K930667 (1994). 112 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202925: KARL STORZ ICG Imaging System, Karl Storz Endoscopy_America, Inc. (2020) Summary page 4.
- K180146: KARL STORZ ICG Imaging System, Karl Storz Endoscopy America, Inc. (2018) Summary page 4.

## Most influential descendants
- K233333: KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit (2023), 2 descendants of its own
- K262547: KARL STORZ TIPCAM1 Rubina (2026), 0 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
- K232857: KARL STORZ ICG Imaging System (2023), 0 descendants of its own

## Indications for use
The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the KARL STORZ Endoscopic ICG System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. Additionally, the KARL STORZ Endoscopic ICG System enables surgeon to perform minimally invasive cranial neurosurgery in adults and pediatrics and endonasal skull base surgery in adults and pediatrics > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging. The KARL STORZ VITOM II ICG System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light. Upon interstitial administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Source page: https://510kreport.com/device/K212695
Methodology: https://510kreport.com/methodology