ECORAY Co., Ltd.

ECORAY Co., Ltd. specializes in high-frequency ultrasound devices. Their portfolio includes models like the ULTRA series (such as ULTRA 100, ULTRA 1060HF, and ULTRA 200A) and the ECOVIEW 9PLUS, which are primarily designed for diagnostic imaging. These devices are used in areas like obstetrics, gynecology, and general abdominal imaging, leveraging advanced ultrasound technology for real-time visualization. The HF-525Plus model may also incorporate hybrid imaging features to improve diagnostic precision.

ECORAY Co., Ltd. is headquartered in South Korea. While the company’s location influences its regulatory jurisdiction, individual devices must comply with the specific requirements of the markets they enter. For example, their devices are registered in the EU’s eudamed database and have undergone FDA 510(k) clearance in the United States, demonstrating compliance with regional regulations for those markets.

ECORAY Co., Ltd.’s devices are listed in the EU’s eudamed database and have undergone FDA 510(k) clearance in the United States. Listing in these registries confirms that the devices meet the necessary safety, performance, and compliance standards for those regions. For example, eudamed registration indicates conformity with EU Medical Device Regulations (MDR), while FDA 510(k) clearance shows that the devices are deemed substantially equivalent to legally marketed predicates in the U.S.

ECORAY Co., Ltd.’s ultrasound devices are classified as Class II and Class IIb under EU regulations. This classification reflects their risk level: Class II devices pose moderate risks and require compliance with specific design controls and clinical evaluations, while Class IIb devices involve higher risks and demand additional scrutiny, such as post-market surveillance and clinical performance data. These classifications ensure that higher-risk devices undergo rigorous assessment to safeguard patient safety.