FDA-Device2017-09-06Class II
Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
Neusoft Medical Systems Co., Ltd.
Hazard
Software defect
Sold states
US Nationwide distribution
Affected count
154
Manufactured in
NO. 16 Shiji Road, Hunnan Industrial Area, Shenyang, N/A, China
Products
Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3045-2017Don't want to check this manually?
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