PerkinElmer Technologies GmbH & Co. KG

PerkinElmer Technologies GmbH & Co. KG specializes in flat panel x-ray detector integration units, such as the XRpad Digital X-Ray Detector System. These devices are engineered to integrate with radiographic imaging systems, enabling high-resolution digital capture of X-ray images for diagnostic use in radiology. The focus is on enhancing image quality and workflow efficiency in medical imaging environments.

The company is headquartered in the United States. While the exact location isn’t specified, its regulatory filings and device listings confirm its operational base within the country, which influences compliance and reporting requirements for its medical devices.

PerkinElmer’s devices, including the XRpad Digital X-Ray Detector System, are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, regulators, and other stakeholders by assigning a standardized identifier to each device model. Listing in the UDI database is a requirement for Class II devices in the U.S.

PerkinElmer’s flat panel x-ray detector integration units, such as the XRpad system, are classified as Class II devices. This classification is determined by the FDA based on factors like the device’s intended use, potential risks, and benefits. Class II devices typically require special controls in addition to general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.