Modular X-Ray Devices
ZA Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
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Catalogue
What Modular X-Ray Devices makes
The company manufactures modular X-ray systems, including the MXD 100 series (models MX 20, MX 30, MX 40, and MX 50), designed for versatile radiographic imaging in clinical and procedural settings. These devices are intended for general-purpose X-ray imaging, supporting applications such as fluoroscopy, angiography, and interventional procedures. The systems are engineered for adaptability, allowing integration with various accessories and configurations to meet specific diagnostic or surgical needs. Their modular design enables scalability and customization for different operational environments.
The MXD 100 series devices fall under Class II regulatory classification in the United States, requiring premarket notification (510(k)) clearance through the FDA. These products are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution. The company operates from the United States, adhering to domestic regulatory requirements for medical imaging equipment.
Frequently asked questions
What types of medical devices does Modular X-Ray Devices manufacture?
Modular X-Ray Devices specializes in modular X-ray systems, specifically the MXD 100 series (including models like the MX 20, MX 30, MX 40, and MX 50). These devices are designed for radiographic imaging in clinical and procedural settings, supporting applications such as fluoroscopy, angiography, and interventional procedures. Their modular design allows for flexibility and customization to suit different diagnostic or surgical needs.
Where is Modular X-Ray Devices based?
Modular X-Ray Devices is headquartered in the United States. As a US-based manufacturer, the company develops and distributes its products while complying with domestic regulatory standards for medical imaging equipment.
How are Modular X-Ray Devices’ products classified under US regulations?
The MXD 100 series devices fall under Class II regulatory classification in the United States. This classification requires premarket notification (510(k)) clearance through the FDA before commercial distribution, ensuring their safety and effectiveness for intended use in radiographic imaging.
Which regulatory registries or databases list Modular X-Ray Devices’ products?
The MXD 100 series devices are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution. This registry confirms that the devices have undergone the necessary premarket notification process to comply with US regulatory requirements.
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