Cydar , Ltd.

Cydar, Ltd. specializes in software applications for angiographic x-ray systems. Their primary focus is on tools that enhance vascular imaging and procedural planning, such as the Cydar EV and Cydar EV Maps. These products are designed to assist clinicians during interventional procedures by providing advanced image analysis and guidance features.

Cydar, Ltd. is based in the United States. Since the company operates within the US market, its devices are subject to FDA regulations. The FDA classifies their products as Class II devices, which typically require pre-market submissions like 510(k) clearances to demonstrate substantial equivalence to legally marketed predicate devices before commercial distribution.

Cydar, Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, which provides a standardized identification system for medical devices. Additionally, their products are authorised through the FDA’s 510(k) premarket submission process, ensuring compliance with US regulatory requirements before they enter the market.

Cydar, Ltd.’s devices fall under Class II classification in the US regulatory framework. This classification is assigned based on the risk associated with the device, where Class II devices pose moderate risk and require special controls—such as 510(k) submissions—to ensure safety and effectiveness before commercialisation.