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Regulatory
affairs

medical certifications

Intended Use

VSI HoloMedicine® is a software device for display of medical images, allowing the visualization of 3D imaging holograms of the patient, on the patient, for preoperative 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 but not restricted to surgeons, radiologists, physicians, and technologists.

Medically Certified in
29 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.

Validated

Medical Certifications

• CE Class 1 (EU)
• HSA Class A approved (Singapore)
• R&D Class II Clinical Study approved (Canada)
• FDA 510(k) is currently under review (USA)

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

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