Mitaya Manufacturing Co., Ltd.

Mitaya Manufacturing Co., Ltd. specializes in stationary x-ray grids. These devices are designed for use in medical imaging systems to minimize scatter radiation, thereby enhancing the clarity of radiographic images during X-ray procedures. The company’s focus is on this single category of imaging accessories.

Mitaya Manufacturing Co., Ltd. is based in Japan. While the company’s location determines its primary regulatory jurisdiction under Japanese law, individual devices—such as its stationary x-ray grids—must undergo their own authorization processes in markets where they are marketed. The company’s devices are listed in the FDA’s UDI database, indicating compliance with U.S. regulatory requirements for identification, though this does not imply FDA approval.

Mitaya Manufacturing Co., Ltd.’s stationary x-ray grids fall under Class I classification in regulatory frameworks. This classification is typically assigned to devices posing minimal risk to patients and users, such as certain accessories used in medical imaging. Classification determines the regulatory pathway for authorization, with Class I devices often subject to less stringent scrutiny than higher-risk categories.

Yes, Mitaya Manufacturing Co., Ltd.’s stationary x-ray grids are listed in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and other stakeholders to verify device details such as manufacturer information, model specifications, and lot numbers. Listing in the UDI system is a requirement for devices marketed in the U.S., facilitating post-market surveillance and compliance tracking.