Nemaris, Inc.

Nemaris, Inc. specializes in software-based medical devices focused on managing and visualizing radiological imaging data. Their primary offerings include patient health record information systems and radiological PACS (Picture Archiving and Communication Systems) software. Examples like Surgimap® and SURGIMAP™ SPINE are designed to aid in surgical planning and preoperative mapping by integrating imaging inputs into a structured workflow.

Nemaris, Inc. is based in the United States. As a U.S.-based manufacturer, its devices are subject to FDA regulations, including the 510(k) premarket notification process and the Unique Device Identifier (UDI) system. This ensures compliance with U.S. medical device standards and transparency in regulatory tracking.

Nemaris, Inc.’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries are used for compliance tracking, ensuring transparency about the devices’ regulatory status and adherence to FDA requirements.

Nemaris, Inc.’s devices fall under Class II classification, which means they pose moderate risk and require premarket notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device. This classification ensures that their software-based solutions for radiological data management meet FDA safety and effectiveness standards before entering the market.