# K241530: Stellar Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Optomedic Technologies, Inc.
- Decided: Aug 7, 2024 after 69 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: 19 generations back to K930667 (1994). 87 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221861: FloNavi Endoscopic Fluorescence Imaging System, Guangdong Optomedic Technologies, Inc. (2023) Summary page 5.

## Most influential descendants
- K252697: 3D Laparoscope (2025), 0 descendants of its own

## Indications for use
UseStellar Imaging System is intended to provide real-time visible and near-infrared imaging in minimally invasive procedures. Upon intravenous administration and use of an ICG agent consistent with its approved label, Stellar Imaging System is used to perform fluorescence imaging and visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts. Upon interstitial administration and use of an ICG agent consistent with its approved label, the Stellar Imaging 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/K241530
Methodology: https://510kreport.com/methodology