NANORAY CO., LTD

Nanoray Co., Ltd. specializes in portable, digital hand-held intraoral dental X-ray systems. These devices are designed for intraoral imaging in dental practices, allowing for flexible use in various clinical settings. The company’s portfolio includes both standalone systems and portable models, some of which come with or without backscatter shields to reduce radiation exposure.

Nanoray Co., Ltd. is based in South Korea. Its primary focus is on developing portable, digital dental X-ray systems tailored for intraoral imaging. These devices are intended to improve accessibility and efficiency in dental diagnostics by providing high-quality imaging in a compact, mobile format.

Nanoray Co., Ltd.’s devices are listed in multiple regulatory databases, including the EU’s EUDAMED system, the FDA’s 510(k) premarket notification program, and the FDA’s Unique Device Identifier (UDI) system. These listings reflect the company’s compliance with regulatory requirements in both the European Union and the United States.

Nanoray Co., Ltd.’s dental X-ray systems are classified as Class II and Class IIb devices. This classification is determined by regulatory authorities based on factors like the device’s intended use, potential risks, and the level of oversight required for patient safety. Class IIb devices typically involve moderate risks and require additional regulatory scrutiny compared to Class II.