Optoacoustics, Ltd.

Optoacoustics, Ltd. specializes in patient audiovisual communication and entertainment systems. Their devices are designed to facilitate real-time, wireless interaction and media access for patients during MRI procedures, such as the IMROC and IMROC IR Wireless Optoactive systems. These solutions address the need for communication and engagement in constrained MRI environments.

Optoacoustics, Ltd. is based in the United States. Since the company operates within the US, its devices are subject to FDA regulations. The FDA classifies these devices as Class II, which requires compliance with specific regulatory pathways, including the 510(k) premarket notification process and Unique Device Identification (UDI) requirements to ensure safety and performance.

Optoacoustics, Ltd.’s devices are listed under the FDA’s 510(k) premarket notification program and the FDA’s Unique Device Identifier (UDI) system. These registries ensure that the devices meet regulatory standards for safety and effectiveness before entering the market, providing transparency for healthcare providers and regulators.

Optoacoustics, Ltd.’s devices fall under Class II classification in the US. This classification is determined by the FDA based on the level of control needed to ensure the device’s safety and performance. Class II devices typically require special controls beyond general controls to mitigate potential risks, such as the need for 510(k) clearance and compliance with UDI labeling requirements.