Moonray Mobile C-Arm
by Simad S.R.L. Italy 510(k)
510(k) K013426 Product code OXO
Overview
The Moonray Mobile C-Arm is an Image-Intensified Fluoroscopic X-Ray System, Mobile, designed for real-time radiographic imaging. It employs a mobile C-arm configuration to provide intraoperative and diagnostic fluoroscopy, enabling precise visualization of skeletal structures and internal procedures in dynamic settings.
This device is supplied as a reusable medical instrument, intended for use in radiology and surgical environments. It is classified as Class II under FDA regulations and has received FDA 510(k) clearance (K013426). The system is not MRI-compatible and requires proper storage and maintenance to ensure sterility and operational integrity. Authorizations include registration numbers under 892.1650 and multiple FEI numbers for tracking.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013426 | Date26 Mar 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OXO
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
Discover our full range of mobile C-arms for radiology surgery and diagnostic application.
The Moonray 500 main unit comprises a compact and versatile C-arm, a 19″ monitor on swing arm, simplified user interface and a large format high resolution monitor with live display function, integrated into the stand.
Other devices from Simad S.R.L.
Questions
Is the Moonray Mobile C-Arm designed for use in MRI environments, and if not, what precautions should be taken during use?
No, the Moonray Mobile C-Arm is explicitly stated as not MRI-compatible. Since it uses X-ray technology, it should never be brought into an MRI suite due to the risk of interference with magnetic fields, which could damage both the device and the MRI system. Always ensure the device is stored and used in non-MRI areas, and follow facility protocols for transporting radiographic equipment near MRI environments.
How is the Moonray Mobile C-Arm maintained to ensure sterility and operational integrity, given it is a reusable device?
The Moonray Mobile C-Arm is designed for reuse in radiology and surgical settings, so proper storage and maintenance are critical. While the device itself is reusable, its components that come into contact with patients (e.g., image intensifier or fluoroscopy accessories) should follow facility-specific decontamination protocols—typically involving cleaning, disinfection, and sterilization as per regulatory guidelines. The manufacturer recommends adhering to standard operating procedures for reusable radiographic equipment to preserve functionality and sterility.
What types of procedures or specialties would benefit most from using the Moonray Mobile C-Arm, and how does its mobility factor into its utility?
The Moonray Mobile C-Arm is primarily designed for real-time radiographic imaging in dynamic settings, making it ideal for radiology and surgical specialties where intraoperative visualization is required. Its mobile C-arm configuration allows for flexibility in operating rooms, trauma bays, or interventional suites, enabling precise imaging of skeletal structures and internal procedures—such as orthopedic surgeries, vascular interventions, or spinal procedures—without the need for fixed fluoroscopy systems. The mobility ensures adaptability to various clinical environments.
Are there specific regulatory identifiers or tracking numbers associated with the Moonray Mobile C-Arm that buyers or clinicians should be aware of?
Yes, the Moonray Mobile C-Arm is tracked using multiple FDA Establishment Inspection (FEI) numbers and a registration number (892.1650) for compliance and recall purposes. Key identifiers include the FDA 510(k) clearance number (K013426) and a list of FEI numbers (e.g., 3013099020, 3027339477, etc.), which may be referenced in facility records or for reporting adverse events. These numbers help ensure traceability and regulatory alignment with the device’s submission history.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K013426