Regulatory affairs

MEDICAL CERTIFICATIONS

intended Use

EU

“VSI HoloMedicine® is a software device for displaying 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.

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. 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.

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

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.

Certified As a Medical Device in 33 Countries

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

VALIDATED

Medical certifications

FDA 510(k) – Approved (USA)


Class I – Registered (EU)
CE

Class A – Approved (SG)
HSA 

Class I – Registered (UK)
MHRA 

Class I – Registered (NZ)
WAND 

Class A – Approved (MY) MDA

COMPLIANT

Quality controls

Compliant

  • QSR 21 CFR Part 820

  • EN ISO 14971:2019+A11:2021

  • EN 62304:2006+A1:2015
  • HIPAA
  • GDPR

Certified

  •  EN ISO 13485:2016+A11 :2021 (MDSAP)

Trusted and secured

COMPLIANT

Are You Ready to Experience Medical mixed reality ?