FDA-Device2020-08-05Class II
Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).
Shanghai United Imaging Healthcare Co., Ltd.
Hazard
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Sold states
US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.
Affected count
5 units
Manufactured in
No. 2258 Chengbei Rd, Jiading Ind., N/A, Shanghai, N/A, China
Products
Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2703-2020Don't want to check this manually?
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