FDA-Device2017-09-06Class II
Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
NeuroLogica Corporation
Hazard
When performing the Stitching function on GU60A system, unintended area is exposed to radiation
Sold states
Nationwide Distribution
Affected count
87 units
Manufactured in
14 Electronics Ave, N/A, Danvers, MA, United States
Products
Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3036-2017Don't want to check this manually?
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