InnoCare Optoelectronics Corp.

InnoCare Optoelectronics Corp. specializes in X-ray imaging systems, including flat panel detectors for radiography and computed tomography. Their product line includes portable and fixed X-ray detectors like the Yushan V14G, V17G, and V17Ce, as well as detectors with integrated Digital Radiography and Online Computing (DROC) systems. These devices are designed for medical imaging applications, enabling real-time image processing and viewing where needed.

InnoCare Optoelectronics Corp. is headquartered in Taiwan. The company’s location in Taiwan supports its focus on developing advanced X-ray imaging technology for global medical markets.

InnoCare Optoelectronics Corp.’s devices are listed in the EUDAMED registry, which tracks medical devices authorized in the European Union, and the FDA’s 510(k) clearance database, which documents devices cleared for marketing in the United States. These listings reflect compliance with respective regulatory requirements for their Class II and Class IIa devices.

InnoCare Optoelectronics Corp.’s devices fall under EU Class II and Class IIa classifications. This classification is determined based on their intended use in medical imaging, where they pose moderate risks that require stringent design controls and conformity assessments to ensure safety and performance. The classification influences regulatory requirements, such as mandatory conformity assessment procedures.

The DROC (Digital Radiography and Online Computing) functionality integrated into some of InnoCare’s X-ray detectors enables real-time image processing and display. This feature allows clinicians to immediately view and analyze X-ray images at the point of capture, improving diagnostic efficiency and workflow in medical settings. It is particularly useful in environments where quick decision-making is critical.