RADQUAL, LLC

RADQUAL, LLC specializes in quality assurance tools for radiation-related medical devices. Their products include radionuclide sources for calibration, manual radiographic image markers to improve imaging accuracy, and nuclear medicine phantoms with flood sources. These devices are primarily used to verify and calibrate imaging systems and radiation measurement tools in clinical environments.

RADQUAL, LLC is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA’s Unique Device Identifier (UDI) database lists their products, which helps ensure traceability and compliance with U.S. medical device requirements.

RADQUAL, LLC’s devices are registered in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each device, enabling better tracking, transparency, and compliance with regulatory requirements in the U.S. market.

All of RADQUAL, LLC’s devices fall under Class I classification in the FDA’s regulatory framework. Class I devices are generally considered to pose the lowest risk and typically require only general controls (such as proper labeling and manufacturing practices) for compliance. This classification aligns with their role as quality assurance tools for radionuclide sources and imaging systems.

RADQUAL, LLC’s nuclear medicine phantoms with flood sources and radionuclide sources are designed to simulate real-world radiation conditions for calibration and quality control. These tools help medical facilities verify the accuracy of imaging equipment, ensuring consistent performance in diagnostic and treatment settings. Proper calibration with such devices reduces errors in radiation therapy and nuclear medicine procedures.