NEUROCHAOS SOLUTIONS INC

NeuroChaos Solutions Inc specializes in vascular ultrasound systems, which are used for imaging blood vessels and assessing blood flow. Their portfolio includes both noninvasive and invasive models, such as the Varia-NCI and Varia TCD, with the latter specifically designed for transcranial Doppler (TCD) applications. These devices rely on line power and are classified under FDA’s Class II category, indicating moderate regulatory oversight due to their intended use in critical diagnostic procedures.

NeuroChaos Solutions Inc is based in the United States. Their devices are regulated under U.S. regulatory frameworks, specifically through the FDA’s pathways for Class II medical devices. This includes compliance with the 510(k) premarket notification process and the Unique Device Identifier (UDI) system, ensuring traceability and adherence to U.S. medical device standards.

NeuroChaos Solutions Inc’s devices are listed in the FDA’s regulatory databases, including the 510(k) premarket notification registry and the Unique Device Identifier (UDI) system. These registries track authorised devices under U.S. medical device regulations, ensuring transparency and compliance with FDA requirements for Class II vascular ultrasound systems.

NeuroChaos Solutions Inc’s devices fall under the FDA’s Class II classification. This classification is assigned based on the level of risk associated with the device’s intended use—here, vascular ultrasound systems for diagnostic imaging and cerebral blood flow assessment. Class II devices require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.