# Stellar Imaging System

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/stellar-imaging-system-gcj>
- Manufacturer: [Guangdong Optomedic Technologies, Inc.](https://devicerts.com/manufacturers/fda-fei-3029968414) (China)
- Device class: Class II (US FDA)
- FDA product code: GCJ

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The Stellar Imaging System is a 3D dual-channel optical endoscope designed for advanced gastrointestinal and urological imaging. It integrates optical technology to provide natural depth perception, enabling precise visualization of internal anatomical structures during procedures.

This system is supplied with configurable camera head options, including 4K resolution and multi-modal imaging capabilities such as white light (2D/3D), indocyanine green (ICG), and methylene blue (MB). It is intended for reusable use in clinical settings, supported by a dedicated cart accommodating 32-inch 4K monitors. The device holds FDA 510K clearance and MDR authorization.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K241530 · decision 2024-08-07 · decision SESE · status: Active
- **EUDAMED** · CE/MDR · European Union · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K241530 [FDA 510(k)]
- FDA product code: GCJ [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 876.1500 [FDA 510(k)]
- Advisory committee: Gastroenterology, Urology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Stellar Imaging System, Guangdong Optomedic Technologies, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/stellar-imaging-system-gcj (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/stellar-imaging-system-gcj.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/stellar-imaging-system-gcj
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.