# K260318: 4K NIR/ICG Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Healnoc Technology Co., Ltd.
- Decided: May 26, 2026 after 116 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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: 18 generations back to K930667 (1994). 86 ancestors in all.
No later device cites it as a predicate yet.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182606: PINPOINT Endoscopic Fluorescence Imaging System, Novadaq Technologies Ulc. (Now A Part of Stryker) (2018) Summary page 5.

## Indications for use
Endoscopic Camera System: Upon intravenous administration and use of an ICG consistent with its approved label, the Endoscopic Camera System is intended to provide real-time endoscopic visible and near-infrared fluorescence visualization. The System enables surgeons to perform minimally invasive surgery using standard endoscope 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, using near-infrared imaging. Upon interstitial administration and use of an ICG consistent with its approved label, the Endoscopic Camera System is intended to be used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Endoscopic Cold Light Source: The Endoscopic Cold Light Source in combination with the camera head and camera control unit is used for visualizing endoscopic procedures.

Source page: https://510kreport.com/device/K260318
Methodology: https://510kreport.com/methodology