FDA-Device2024-11-13Class II
SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Hazard
X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.
Sold states
US Nationwide distribution in the states of CA, CT, MA, WV, OH, NY, IA, NE, MN, IL, FL, NC, HI, LA, MD, MT, WA, AR, TX, TN, CO.
Affected count
3
Manufactured in
Nishinokyo Kuwabara -Cho, Nakagyo-Ku; 1, Kyoto, N/A, Japan
Products
SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0316-2025Don't want to check this manually?
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