FDA-Device2016-03-23Class II
Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).
Deerfield Imaging
Hazard
Emergency helium venting lines (i.e. quench lines) may not have been properly installed.
Sold states
Worldwide Distribution -- US, including the states of CA, CT, FL, GA, IL, IN, MD, MA, MN, MO, NH, NC, OH, OR, PA, TX, UT, VA, and WI; and ,countries of CHINA, CANADA, AUSTRALIA, FRANCE, JAPAN, and GERMANY.
Affected count
35 USA, 14 OUS
Manufactured in
5101 Shady Oak Rd S, Minnetonka, MN, United States
Products
Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1098-2016Don't want to check this manually?
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