Stellar Imaging System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241530 FDA 510(k)
- FDA Product Code
- GCJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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.
Frequently asked questions
What types of procedures is the Stellar Imaging System primarily designed for, and how does its 3D imaging help during these procedures?
The Stellar Imaging System is designed for advanced gastrointestinal and urological procedures, where precise visualization of internal structures is critical. Its 3D dual-channel optical endoscope provides natural depth perception, which enhances spatial awareness during interventions like biopsies, polyp removals, or bladder/ureter evaluations. The 3D capability reduces operator fatigue and improves accuracy compared to traditional 2D imaging, particularly in complex or narrow anatomical areas.
Does the Stellar Imaging System support multiple imaging modes, and what are the practical benefits of using these modes during a procedure?
Yes, the Stellar Imaging System includes multi-modal imaging capabilities: white light (2D/3D), indocyanine green (ICG), and methylene blue (MB). White light provides standard anatomical visualization, while ICG fluorescence highlights vascular structures (e.g., during colorectal or urological surgeries), and methylene blue can aid in identifying lymph nodes or tissue perfusion. These modes allow clinicians to adapt imaging dynamically based on procedural needs, improving diagnostic confidence and procedural outcomes.
How is the Stellar Imaging System supplied, and what should clinicians consider regarding its reusable nature and maintenance?
The Stellar Imaging System is supplied as a reusable clinical device, paired with a dedicated cart that accommodates 32-inch 4K monitors for optimal visualization. Since it’s reusable, clinicians must follow the manufacturer’s cleaning, disinfection, and sterilization protocols to ensure safety and longevity. Proper maintenance—including camera head calibration and software updates—is essential to preserve image quality and functionality over repeated use. The system’s durability is designed for high-volume clinical settings.
What camera head options are available for the Stellar Imaging System, and how might these choices affect procedural workflow?
The Stellar Imaging System offers configurable camera head options, including 4K resolution and multi-modal imaging. The choice of camera head depends on the procedure: a high-resolution 4K head ensures detailed visualization for intricate tasks (e.g., endoscopic mucosal resections), while multi-modal heads (supporting ICG/MB) expand utility for fluorescence-guided surgeries. Clinicians should select based on their workflow needs—e.g., urologists may prioritize ICG for vascular assessment, while gastroenterologists might favor 3D white light for polyp inspection.
How does the Stellar Imaging System’s regulatory pathway (FDA 510K and MDR) impact its availability and clinical adoption?
The Stellar Imaging System holds FDA 510K clearance (determined as *Substantially Equivalent* to a predicate device) and MDR authorization, confirming its compliance with U.S. and EU regulatory standards. This pathway ensures the device meets safety and performance requirements for gastrointestinal and urological imaging, validating its clinical use in both markets. For buyers, this means the system is legally marketable in the U.S. and EU without additional country-specific hurdles, streamlining procurement and adoption in regulated healthcare settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Stellar-Guangdong OptoMedic Technologies, Inc., Stellar-Guangdong OptoMedic Technologies, Inc., Stellar-Guangdong OptoMedic Technologies, Inc., Guangdong OptoMedic Technologies, Inc., Products & Solutions-Guangdong OptoMedic Technologies, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K241530 | Class II | Active |
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Manufacturer
- Manufacturer
- Guangdong Optomedic Technologies, Inc.
Sources (2)
- FDA 510(k) K241530 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026