Garion Mobile Image-Intensified Fluoroscopic X-Ray System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- GARION+ EUDAMEDGARION EUDAMED
- Device Name
- Mobile C-arm X-ray System EUDAMED
- Model / Reference
- GARION EUDAMEDGARION+ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809365283040 EUDAMED08809365283033 EUDAMED
- Basic UDI-DI
- 880936528MCASB EUDAMED
- Direct Marketing DI
- 08809365283040 EUDAMED08809365283033 EUDAMED
- 510(k) Number
- K222080 FDA 510(k)
- FDA Product Code
- OWB FDA 510(k)
- EMDN Code
- Z11039009 FLUOROSCOPY DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1650 FDA 510(k)
- Regulation Number
- 892.1650 FDA 510(k)
- Market of Registration
- Spain EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Garion Mobile Image-Intensified Fluoroscopic X-Ray System is a mobile interventional fluoroscopic X-ray device designed for real-time imaging during surgical and diagnostic procedures. It employs an image-intensifier to amplify X-ray signals, enabling high-contrast visualization of internal structures, including bones, vessels, and implanted devices, in dynamic settings such as angiography, orthopedics, and cardiology interventions.
This system is intended for use in clinical environments requiring portability, such as operating rooms, catheterization labs, and emergency departments. Supplied as a reusable device, it undergoes sterilization processes to ensure safety for repeated use. The system adheres to MRI safety standards for non-MRI environments and is authorized under FDA 510(k) clearance and MDR compliance. Multiple model and registration numbers are associated with its regulatory submissions, reflecting its classification as a Class II device under the OpenFDA database.
Frequently asked questions
What types of clinical procedures is the Garion Mobile Image-Intensified Fluoroscopic X-Ray System primarily used for?
The Garion Mobile Image-Intensified Fluoroscopic X-Ray System is designed for real-time imaging during surgical and diagnostic procedures, particularly in dynamic settings like angiography, orthopedics, and cardiology interventions. Its image-intensifier technology enables high-contrast visualization of internal structures such as bones, blood vessels, and implanted devices, making it ideal for procedures requiring precise guidance.
Is the Garion Mobile Image-Intensified Fluoroscopic X-Ray System reusable, and if so, how is it sterilized?
Yes, the Garion Mobile Image-Intensified Fluoroscopic X-Ray System is supplied as a reusable device. It undergoes sterilization processes to ensure safety for repeated use in clinical environments, though the specific sterilization methods are not detailed in the provided data.
What regulatory pathways has the Garion Mobile Image-Intensified Fluoroscopic X-Ray System followed, and what does that mean for its use?
The device has been authorized under FDA 510(k) clearance and MDR compliance, confirming it meets regulatory standards for safety and effectiveness. This means it has undergone evaluation by the FDA and EU authorities, ensuring it is suitable for use in clinical settings like operating rooms, catheterization labs, and emergency departments where portability is required.
How many model or registration variants of this device exist, and what does that indicate about its versatility?
The device has multiple registration numbers (e.g., 3005706667, 3003768277, etc.) and FEI numbers (e.g., 3002619595, 3005706667, etc.), totaling dozens of entries in regulatory databases. This suggests a range of configurations or variants may exist, allowing for flexibility in clinical applications across different procedural needs while maintaining compliance with regulatory requirements.
Where can the Garion Mobile Image-Intensified Fluoroscopic X-Ray System be used, and why is portability important for this device?
The system is designed for use in clinical environments requiring portability, such as operating rooms, catheterization labs, and emergency departments. Portability ensures real-time imaging can be performed wherever it’s needed, reducing the need for patients to be moved to fixed imaging stations and enabling interventions in dynamic or space-constrained 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.
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 | K222080 | Class II | Active |
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Manufacturer
- Manufacturer
- Sg Healthcare Co, Ltd.
Sources (3)
- FDA 510(k) K222080 24 fields · synced Sep 18, 2026
- EUDAMED 9d7c43f3-038a-47ad-8e97-5bb4c368a176 61 fields · synced Jul 14, 2026
- EUDAMED 9fcebd50-ba75-4cf3-830d-7de7dec5172f 61 fields · synced Jul 17, 2026