FDA-Device2017-06-14Class II
NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. Th
Nexstim PLC
Hazard
Software defect: the NBS software may accidentally generate duplicate copies of one or several files.
Sold states
Worldwide Distribution - US to GA only, Foreign: Europe
Affected count
21
Manufactured in
Elimaenkatu 9B, N/A, Helsinki, N/A, Finland
Products
NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2320-2017Don't want to check this manually?
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