VISUS Health IT GmbH

VISUS Health IT GmbH specializes in radiological Picture Archiving and Communication Systems (PACS) software. Their primary product, JiveX, is designed to digitize, store, and manage medical imaging data for hospitals and clinics, facilitating seamless integration with imaging equipment and workflow automation in radiology departments.

VISUS Health IT GmbH is based in Germany. Their devices are classified under the EU Medical Device Regulation (MDR) as Class II and Class IIa, reflecting moderate to higher-risk categorization for software used in medical imaging workflows. Their products are listed in the EUDAQS database (eudamed) and the FDA’s 510(k) and UDI systems, demonstrating compliance with both European and US regulatory requirements.

VISUS Health IT GmbH’s devices are recorded in multiple regulatory registries, including the EU’s eudamed database (EUDAQS), the FDA’s 510(k) premarket notification system, and the FDA’s Unique Device Identifier (UDI) database. These listings ensure transparency and traceability of their radiological PACS software, JiveX, across international markets.

Under the EU Medical Device Regulation (MDR), VISUS Health IT GmbH’s PACS software (e.g., JiveX) is classified as Class II or Class IIa devices. This classification is based on factors like the software’s role in managing critical medical imaging data and its potential impact on patient safety. In the US, their devices are tracked through the FDA’s 510(k) pathway for moderate-risk devices and the UDI system for traceability, ensuring alignment with both regional risk-based frameworks.