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510(k) Data Aggregation
K Number
K112881Device Name
NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
Manufacturer
NEXSTIM OY
Date Cleared
2012-05-22
(235 days)
Product Code
GWF, HAW, IKN
Regulation Number
882.1870Why did this record match?
Applicant Name (Manufacturer) :
NEXSTIM OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nexstim Navigated Brain Stimulation System (NBS System) 4 is indicated for non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System 4 provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning.
Nexstim NEXSPEECH®, when used together with the Nexstim NBS System 4, is indicated for noninvasive localization of cortical areas that do not contain essential speech function. Nexstim NEXSPEECH® provides information that may be used in pre-surgical planning in patients undergoing brain surgery. Intraoperatively, the localization information provided by NEXSPEECH® is intended to be verified by direct cortical stimulation.
The Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® are not intended to be used during a surgical procedure. The Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® are intended to be used by trained clinical professionals.
Device Description
The NBS System 4 combines magnetic resonance imaging-based, three dimensional localization of cortical motor areas of the brain with noninvasive TMS and simultaneous electromyography measurement to locate areas of the brain that are capable of evoking muscle responses when stimulated.
NEXSPEECH® is intended to be used in conjunction with the NBS System 4 for localization and assessment of cortical areas of speech function for pre-procedural planning purposes.
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K Number
K091457Device Name
NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM
Manufacturer
NEXSTIM OY
Date Cleared
2009-12-08
(204 days)
Product Code
GWF, HAW, IKN
Regulation Number
882.1870Why did this record match?
Applicant Name (Manufacturer) :
NEXSTIM OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nexstim eXimia Navigated Brain Stimulation System (NBS System) is indicated for non-invasive 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.
Device Description
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