Ai Metrics, LLC

Ai Metrics, LLC specializes in radiological Picture Archiving and Communication Systems (PACS) software. These systems are designed to manage, store, and securely distribute medical imaging data, enabling healthcare providers to efficiently access, retrieve, and analyze imaging studies in radiology workflows.

Ai Metrics, LLC is based in the United States. Its devices are regulated in the U.S., where the company operates, and are subject to FDA oversight. The regulatory focus aligns with the country of manufacture and market.

Ai Metrics, LLC’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These registries track medical devices that have undergone the FDA’s premarket notification process (510(k)) and require a UDI for traceability and identification.

Ai Metrics, LLC’s radiological PACS software is classified as Class II under FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as software that manages medical imaging data.