FDA-Device2020-11-18Class II
Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).
Shanghai United Imaging Healthcare Co., Ltd.
Hazard
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
Sold states
US Nationwide distribution including in the state of TX.
Affected count
4
Manufactured in
No. 2258 Chengbei Rd, Jiading Ind., Shanghai, China
Products
Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0445-2021Don't want to check this manually?
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