PROFESSIONAL ECONOMICS BUREAU OF AMERICA INC

Professional Economics Bureau of America Inc specializes in software applications for general-purpose dental X-ray systems. Their primary focus is on tools like ImageXL, which are designed to improve imaging workflows and streamline data management in dental radiography. These solutions are software-based and do not include physical hardware.

The company is based in the United States. This location is relevant for regulatory considerations, as it influences compliance requirements and reporting standards for their devices.

The devices produced by Professional Economics Bureau of America Inc fall under the FDA’s Class II regulatory category. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as software for dental imaging that impacts workflow and data integrity.

Yes, the devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability for healthcare providers, regulators, and other stakeholders.