Stellar Imaging System
by Guangdong Optomedic Technologies, Inc.
510(k) K241530
Active
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK241530 | Date7 Aug 2024 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Official records
Across registries
- FDA 510(k) K241530 decided 7 Aug 2024 Active
- EUDAMED Active
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA product code
- GCJ
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
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.
Devices cleared under K241530
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| 3D Laparoscope 21033SA | 21033SA | 06973031299344 | — | On the market |
| 3D Laparoscope 21033SC | 21033SC | 06973031299337 | — | On the market |
| Stellar 3D Camera Head SC10D | SC10D | 06973031299405 | — | On the market |
| Stellar 3D Fluorescence Camera Head SC20D | SC20D | 06973031299399 | — | On the market |
| Stellar Camera Head SC10E | SC10E | 06973031299429 | — | On the market |
| Stellar Exoscope 31103FA | 31103FA | 06973031299382 | — | On the market |
| Stellar Fluorescence Camera Head SC20E | SC20E | 06973031299412 | — | On the market |
| Stellar Image Processing Unit SI10E | SI10E | 06973031299436 | — | On the market |
| Stellar Light Source SL10 | SL10 | 06973031299375 | — | On the market |
| Stellar Light Source SL20 | SL20 | 06973031299504 | — | On the market |
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