Icat Solutions, Ltd.

Icat Solutions, Ltd. specializes in radiology picture archiving and communication system (PACS) workstations and mobile applications. These devices are primarily designed for viewing and managing medical imaging data, such as DICOM-based archives and studies, to support diagnostic interpretation and clinical workflows in radiology environments. Their products include both desktop and mobile solutions for seamless integration into healthcare settings.

Icat Solutions, Ltd. is based in the United States. Their devices are regulated under U.S. jurisdiction, specifically under the FDA’s classification system. The company’s products fall under the FDA’s Class II category, which indicates moderate risk and requires compliance with specific regulatory controls to ensure safety and effectiveness.

Icat Solutions, Ltd.’s devices are included in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries help track and identify medical devices that have undergone the necessary regulatory processes to demonstrate compliance with U.S. safety and performance standards before entering the market.

Icat Solutions, Ltd.’s devices are classified as Class II under FDA regulations. This classification is determined based on the level of risk associated with the device. Class II devices require special controls in addition to general controls to ensure their safety and effectiveness, as they pose a moderate risk compared to Class I devices but are not as high-risk as Class III devices.