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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.

Validated

Medical Certifications

• FDA 510(k) - Approved (USA)
• CE Class I - Registered (EU)
• HSA Class A - Approved (SG)
• MHRA Class I - Registered (UK)
• WAND Class I - Registered (NZ)
• MDA Class A - Approved (MY)

compliant

Quality Controls

• EN ISO 13458:2016+A11 :2021
• QSR 21 CFR Part 820
• EN ISO 14971:2019+A11:2021
• EN 62304:2006+A1:2015
• MDSAP(USA & EU)

TRUSTED AND SECURED

Regulatory and Quality

FDA 510(k)
Approved (USA)
MHRA Class I
Registered (UK)
MDA Class A
Approved (MY)
CE Class I
Registered (EU)
WAND Class I
Registered (NZ)
ISO 13485:2016
Compliant
HSA Class A
Approved (SG)
MDSAP
(USA & EU)
HIPAA & GDPR
Compliant
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