FDA-Device2020-08-19Class II
OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.
NeuroLogica Corporation
Hazard
There are potential issues related to the operational state of the scanner, specifically for transport and inadvertent system shutdowns. There could be a possibility of potential delay in patient treatment if proper use instructions are not followed.
Sold states
Worldwide distribution - US Nationwide distribution and the countries of Canada, India, Portugal, Singapore, Slovak Republic, Thailand, Turkey, UK.
Affected count
35
Manufactured in
14 Electronics Ave, N/A, Danvers, MA, United States
Products
OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2772-2020Don't want to check this manually?
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