FDA-Device2020-08-19Class II
uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Shanghai United Imaging Healthcare Co., Ltd.
Hazard
1) 1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip in gantry may create sharp edge. May lead to repeat scanning and abrasions.
Sold states
US Nationwide distribution including in the state of Texas.
Affected count
1 unit distributed to Texas
Manufactured in
No. 2258 Chengbei Rd, Jiading Ind., N/A, Shanghai, N/A, China
Products
uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2799-2020Don't want to check this manually?
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