Mirada Medical, Ltd.

Mirada Medical, Ltd. specializes in radiology workstations and software solutions primarily for nuclear medicine and interventional radiology. Their portfolio includes systems like picture archiving and communication (PAC) workstations, treatment planning tools for radioactive isotope therapies (such as yttrium-90 applications), ablation intelligence software, and workflow optimization platforms. These devices support diagnostic imaging, procedural planning, and therapeutic interventions.

Mirada Medical, Ltd. is based in the United States, which means its devices fall under FDA regulatory jurisdiction. The company’s products are authorised through pathways like the 510(k) premarket notification process or the Unique Device Identifier (UDI) system, depending on their classification. The FDA’s databases, such as the 510(k) and UDI registries, list these devices for transparency and compliance tracking.

Mirada Medical’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway (e.g., 510(k) for Class II) and the level of scrutiny applied during authorisation, ensuring appropriate oversight based on the device’s potential impact on patient safety.

Mirada Medical’s devices are listed in the FDA’s 510(k) registry and the Unique Device Identifier (UDI) system. The 510(k) registry provides details on premarket submissions for Class II devices, including summaries of their intended use and safety data. The UDI system assigns a unique identifier to each device, enabling tracking of manufacturing, distribution, and post-market surveillance. These registries help stakeholders verify compliance and traceability of the company’s authorised products.