FDA-Device2021-10-06Class II
uMI 550 System - Product Usage: 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
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
Sold states
U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.
Affected count
23 systems
Manufactured in
No. 2258 Chengbei Rd, Jiading Ind., N/A, Shanghai, N/A, China
Products
uMI 550 System - Product Usage: 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-2593-2021Don't want to check this manually?
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