FDA-Device2020-05-27Class III

ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options

Immersivetouch Inc
Hazard

Observed an internal repetitive software glitch in ImmersiveView.

Sold states
The device was distributed in the state of Illinois only.
Affected count
2 units
Manufactured in
910 W Van Buren St Ste 715, N/A, Chicago, IL, United States
Products
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2041-2020

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