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HoloMedicine® Patient Viewer and VSI HoloMedicine® are regulated medical devices. Both are CE-marked as Class IIa medical devices under Regulation (EU) 2017/745. Market access outside the EU/EEA is stated separately by jurisdiction below. Both are designed, developed and maintained under an ISO 13485:2016 quality management system certified under MDSAP.
The intended-use statement defines the regulated scope per region. Images shown on a head-mounted display or monitor are for informational purposes only and are not intended for primary diagnostic use. Both products are intended for use by qualified healthcare professionals.
"HoloMedicine® provides visualization capabilities for 3D and 2D medical data in DICOM and other file formats."
Covers the VSI HoloMedicine® and HoloMedicine® Patient Viewer product family. Instructions, intended purpose and proper use are available in English here.
"VSI is a software platform to be used by clinicians for the visualization of medical images in 3D to allow for surgical planning activities, patient education, and teaching, offering an intuitive and immersive user experience."
When accessing VSI software from a wireless stereoscopic HMD or mobile device, images viewed are for information purposes only and not intended for diagnostic use, and users should rely on certified diagnostic tools for clinical decisions.
Find all product instructions, intended purpose, and proper use available in English here.
"HoloMedicine® Patient Viewer provides visualization capabilities for 3D and 2D medical data in DICOM and other file formats."
Find all product instructions, intended purpose, and proper use available in English here.
Talk to our regulatory team - we'll walk you through intended use, certifications, and what's covered where.