Ecotron Co., Ltd

Ecotron Co., Ltd specializes in mobile medical imaging devices. Their product line includes mobile fluoroscopic C-arm systems (such as the Anyview-320S, Anyview-240DR, and Anyview-500DR series) and mobile X-ray systems (like the DT-703 and EPX-Series). They also produce standalone fluoroscopic X-ray systems (e.g., Anyview-500R and Anyview-500S) for intraoperative and portable imaging, catering to intraoperative and portable imaging needs.

Ecotron Co., Ltd is headquartered in South Korea. The company’s location is relevant for understanding its regulatory context, as it operates within the regulatory frameworks of its home country and those of markets where its devices are authorized.

Ecotron Co., Ltd’s devices are recorded in the EUDAMED registry for European Union compliance and the FDA’s 510(k) database for U.S. authorization. These registries track device classifications and regulatory statuses, ensuring transparency for healthcare providers and regulators.

Ecotron Co., Ltd’s devices fall under EU Class II and Class IIb classifications. This classification determines the regulatory scrutiny and requirements for their authorization, with Class IIb indicating a higher risk level than Class II, necessitating additional safety and performance evaluations.