FDA-Device2016-05-18Class II
NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
Neusoft Medical Systems Co., Ltd.
Hazard
It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to "Right" in the system setting - scanner options.
Sold states
US Distribution - Including Puerto Rico and the states of IL, CT, SC, NE
Affected count
7 units
Manufactured in
NO. 16 Shiji Road, Hunnan Industrial Area, Shenyang, N/A, China
Products
NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1650-2016Don't want to check this manually?
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