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HoloMedicine® Patient Viewer and VSI HoloMedicine® are regulated medical devices - CE-marked Class IIa and certified across multiple countries, built and maintained inside a certified quality management system.
The intended-use statement defines the regulated scope per region. Images shown on a head-mounted display or monitor are informational only - not for primary diagnosis.
"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 and German 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 EN here.
Talk to our regulatory team - we'll walk you through intended use, certifications, and what's covered where.