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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.

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.

*Please note, features & use cases under FDA 510(k) certification will vary and are not yet available for purchase in the USA territory. Expected release is in Q2 2023.

Medically Certified in
30
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, USA.

*Please note, features & use cases under FDA 510(k) approval will vary and are not yet available for purchase in the USA territory. Expected release is in Q2 2023.

Validated

Medical Certifications

• CE Class 1 (EU)
• HSA Class A approved (Singapore)
• R&D Class II Clinical Study approved (Canada)
• FDA 510(k) Class II – release expected Q2 2023 (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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