ICZ.HEA a.s.

ICZ.HEA a.s. manufactures the AMIS*PACS FLEXSERVER G2, which is a picture archiving and communication system (PACS) designed for medical imaging. This device helps store, retrieve, and distribute digital images and information from medical imaging equipment, supporting efficient workflows in healthcare settings.

ICZ.HEA a.s. is based in the Czech Republic. The company’s location is relevant for regulatory compliance and transparency in the medical device industry, particularly when assessing device authorisation and reporting requirements.

The AMIS*PACS FLEXSERVER G2, manufactured by ICZ.HEA a.s., is listed in the EUDAMED database. This registry is the official European Union portal for medical device information, ensuring traceability and transparency for stakeholders like regulators, healthcare providers, and patients.

The AMIS*PACS FLEXSERVER G2 falls under Class IIb classification according to EU medical device regulations. This classification is determined by factors such as the device’s intended purpose, potential risks, and the level of oversight required to ensure patient safety and device performance.