Here you can find interesting useful information and answers to frequently-asked questions about X-rays in general, about our digital X-ray systems and other products, as well as about our company.
This section is regularly updated. There is something new every time you visit – it's worth stopping by from time to time.
Legal information
According to the Medical Device Regulation, which has been in force since May 2021, when replacing individual components of a digital X-ray system, it must be proven that the replacement part does not impair the safety and performance of the product. EXAMION meets these requirements through its highly trained technical department and its extensive quality control management documentation.
The legal basis for placing X-ray equipment on the market is regulated in the Medical Device Regulation. There are two forms approval for market circulation of an X-ray product: An X-ray system can be sold either as a fully certified product or as a treatment unit. EXAMION's digital X-ray systems are fully certified products.
Clear regulations apply to medical devices to ensure their proper functionality and to protect patients from harm. The Picture Archiving and Communication System (PACS) is used to capture and display medical image data, and therefore exerts considerable influence over viewing options and the associated diagnosis. This justifies the classification of the PACS as a medical device. The EXAMION X-AQS PACS is approved according to the European Medical Device Directive MDD (93/42/EEC) and is awaiting certification in accordance with the new Medical Device Regulation MDR (2017/745/EU). Our X-ray software has been developed in compliance with IEC 62304:2006-05.