# K180146: KARL STORZ ICG Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy America, Inc.
- Decided: Apr 17, 2018 after 89 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K930667 (1994). 93 ancestors in all.
30 later devices descend from it; 4 cite it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171238: KARL STORZ ICG Imaging System, KARL STORZ Endoscopy-America, Inc. (2017) Summary page 4.
- K021050: Ksea Neuroendoscopes and Accessories, KARL STORZ Endoscopy-America, Inc. (2002) Summary page 4.
- K162882: KARL STORZ ICG Imaging System, KARL STORZ Endoscopy-America, Inc. (2017) Summary page 9.

## Most influential descendants
- K211202: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes (2021), 19 descendants of its own
- K214046: 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable (2022), 14 descendants of its own
- K221611: 780 nm L11 LED Light Source with AIM (2022), 10 descendants of its own
- K230216: 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) (2023), 8 descendants of its own
- K201399: HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head (2020), 8 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. 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, or 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.

Source page: https://510kreport.com/device/K180146
Methodology: https://510kreport.com/methodology