Cirdan Imaging Limited

Cirdan Imaging Limited specializes in laboratory information management solutions, including software applications for blood bank and clinical laboratory workflows. Their portfolio includes systems like the Ultra Laboratory Information System and Ultra Transfusion Medicine, which support transfusion medicine processes. Additionally, they offer hardware like the CoreLite X-Ray Specimen Cabinet, a tissue specimen X-ray system designed for diagnostic imaging. These devices help streamline specimen tracking, imaging, and data management in clinical and research environments.

Cirdan Imaging Limited is based in the United States. Their devices are primarily regulated within the U.S. regulatory framework, where they fall under FDA oversight. The company’s products are authorised through pathways like the 510(k) clearance process or listed in the FDA’s Unique Device Identifier (UDI) database, depending on the device classification.

Cirdan Imaging Limited’s devices are classified under two main FDA categories: Class I and Class II. Class I devices generally pose the lowest risk and may require less regulatory scrutiny, while Class II devices involve moderate risk and typically require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as 510(k) clearance for Class II devices, ensuring compliance with FDA requirements.

Cirdan Imaging Limited’s devices are listed in key U.S. regulatory databases, including the FDA’s 510(k) clearance registry for certain products and the FDA’s Unique Device Identifier (UDI) database. These registries help track authorised devices, ensuring transparency and compliance with U.S. medical device regulations.

The tissue specimen X-ray system, such as the CoreLite X-Ray Specimen Cabinet, is designed for diagnostic imaging of tissue samples. It helps clinicians and researchers visualise specimens to aid in accurate diagnosis, research, or procedural planning. By integrating imaging capabilities with specimen tracking, the system supports workflow efficiency in clinical and laboratory settings.