Intuitive Imaging Informatics, LLC

Intuitive Imaging Informatics, LLC specializes in radiology picture archiving and communication system (PACS) workstations. These devices are designed to store, retrieve, and display medical imaging data, enabling healthcare providers to efficiently manage digital imaging studies in clinical settings. Examples include standalone and integrated PACS solutions like ImageQube and RATIONAL IMAGING PACS.

The company is headquartered in the United States. While the exact location isn’t specified, its regulatory filings and device listings indicate it operates within the U.S. market, where its products are intended for use.

Intuitive Imaging Informatics, LLC’s devices are listed in the FDA’s regulatory databases, specifically under the 510(k) premarket notification process and the Unique Device Identifier (UDI) system. These registries ensure compliance and traceability for Class II medical devices intended for the U.S. market.

The company’s PACS workstations fall under FDA Class II device classification. This classification requires compliance with specific regulatory controls, including performance standards and post-market surveillance, to ensure safety and effectiveness in clinical environments.