VAREX IMAGING WEST, LLC

Varex Imaging West, LLC specializes in indirect flat panel x-ray detectors, such as the XRPad2 and XRpad models. These devices convert X-ray exposure into digital signals, enabling high-quality radiographic imaging for diagnostic purposes in radiology. Their focus is on enhancing digital imaging systems for medical use.

The company is based in the United States, which means its devices must comply with U.S. regulatory requirements, including those set by the FDA. Since its products fall under Class II medical devices, they undergo specific regulatory pathways to ensure safety and performance before entering the market.

Yes, the company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This listing provides a standardized way to track and identify each device, ensuring transparency in the supply chain and aiding healthcare providers, regulators, and manufacturers in monitoring device performance and compliance. It also supports traceability for recalls or post-market surveillance.

The company’s devices are classified as Class II medical devices under FDA regulations. This classification indicates they pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. While they don’t require pre-market approval, they must still meet specific labeling, manufacturing, and performance standards to maintain compliance.