Regulatory
affairs

medical certifications

Intended Use

EU & Singapore

VSI HoloMedicine® is a software device for displaying of medical images and allowing the visualization of 3D imaging holograms outside and/or inside the surgical room. VSI HoloMedicine® is indicated for use by qualified healthcare professionals, including but not restricted to surgeons, radiologists, physicians, and technologists. When accessing VSI HoloMedicine® from a wireless head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use.

Find all product instructions, intended purpose, and proper use available in EN and DE here.

USA

VSI HoloMedicine^® is a software device for displaying digital medical images acquired from CT, Angio CT, MRI,CBCT, PET, and SPECT sources. It is intended to visualize 3D imaging holograms of the patient for pre-operative planning outside and/or inside the surgical room. When accessing VSI HoloMedicine^® from a wireless head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. VSI HoloMedicine^® is indicated for use by qualified healthcare professionals including surgeons, radiologists, physicians, and technologists.

Find all product instructions, intended purpose, and proper use available in EN and DE here.

*Please note, features & use cases in the USA are subject to the FDA 510(k) certification.

Medically Certified in
31
countries

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Singapore, Slovakia, Slovenia, Spain, Sweden, Turkey, UK, USA.

*Please note, features & use cases in the USA are subject to the FDA 510(k) certification.

Validated