Ortho2, LLC

Ortho2, LLC specializes in radiological Picture Archiving and Communication System (PACS) software. Their primary focus is on tools tailored for orthopedic imaging workflows, including software like SmartCeph, which is designed for digital cephalometric analysis. This software aids in radiologic measurements and assessments used in orthodontic and maxillofacial evaluations.

Ortho2, LLC is based in the United States. Their devices fall under U.S. regulatory jurisdiction, specifically the FDA’s classification system. The company’s PACS software, including tools like SmartCeph, is classified as Class II, indicating a moderate level of regulatory oversight.

Ortho2, LLC’s devices are listed in the FDA’s 510(k) database, which tracks premarket notifications for Class II devices, and the FDA’s Unique Device Identifier (UDI) database, which standardizes device labeling for tracking and identification purposes. These registries help ensure transparency and traceability of their radiological PACS software.

Ortho2, LLC’s devices, such as their radiological PACS software and cephalometric analysis tools, are classified as Class II under FDA regulations. This classification is based on the level of risk associated with the device, where Class II devices require special controls in addition to general controls to ensure safety and effectiveness, such as those used in orthodontic imaging workflows.