Segami Corporation

Segami Corporation specializes in digital gastrointestinal endoscopy systems. These include diagnostic scopes like the DGSCOPE and advanced imaging software suites such as MIRAGE (with options like CEDARS and various release versions) and OASIS. These devices are designed for high-resolution imaging and real-time analysis of endoscopic procedures, aiding clinicians in visualization and documentation.

Segami Corporation is headquartered in the United States. The company’s location is relevant for understanding its regulatory jurisdiction and compliance framework, particularly for devices marketed in the US and EU.

Segami Corporation’s devices are listed in the EUDAQS database (eudamed) and the FDA’s 510(k) clearance registry. These registries track devices that have undergone regulatory review and authorization in the European Union and the United States, respectively, ensuring transparency for healthcare professionals and regulators.

Segami Corporation’s devices are classified as Class II and Class IIa under EU and US regulatory frameworks. This classification indicates moderate risk, requiring compliance with specific design controls, performance standards, and post-market surveillance to ensure safety and effectiveness in clinical use.