FDA-Device2024-10-02Class II
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
FUJIFILM Healthcare Americas Corporation
Hazard
When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected.
Sold states
US Nationwide and Worldwide
Affected count
130
Manufactured in
81 Hartwell Ave, Ste 300, Lexington, MA, United States
Products
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3158-2024Don't want to check this manually?
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