Z MICROSYSTEMS, INC.

Z Microsystems, Inc. specializes in endoscopic video image processing units, such as the Clarity system. These devices are designed to improve and process real-time video feeds during endoscopic procedures, ensuring clearer visualization for medical professionals.

The company is headquartered in the United States. This location allows it to comply with U.S. regulatory requirements, including those for medical device classification and listing.

Z Microsystems, Inc.’s endoscopic video image processing units, like the Clarity system, are classified as Class II devices by the FDA. This classification is based on their intended use and risk level, requiring compliance with specific controls to ensure safety and effectiveness.

Yes, the company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. Listing in the UDI system ensures traceability and transparency in the medical device supply chain, helping healthcare providers and regulators track devices throughout their lifecycle.