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Found 4 results
510(k) Data Aggregation
K Number
K071697Device Name
NEURONAV SYSTEM AND NEURONAV DRIVE
Manufacturer
ALPHA OMEGA LTD.
Date Cleared
2007-12-03
(166 days)
Product Code
GZL
Regulation Number
882.1330Why did this record match?
Applicant Name (Manufacturer) :
ALPHA OMEGA LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K051830Device Name
NEURODRIVE SYSTEM
Manufacturer
ALPHA OMEGA LTD.
Date Cleared
2005-09-16
(72 days)
Product Code
GZL
Regulation Number
882.1330Why did this record match?
Applicant Name (Manufacturer) :
ALPHA OMEGA LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Alpha Omega NeuroDrive system is intended to be used to Assist neurosurgeons in the operating room during functional neurosurgery and to aid in the placement of depth electrode.
Device Description
NeuroDrive system
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K Number
K013396Device Name
ALPHA DRIVE SYSTEM
Manufacturer
ALPHA OMEGA LTD.
Date Cleared
2002-08-07
(296 days)
Product Code
HAW
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
ALPHA OMEGA LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Alpha Omega Alpha Drive system is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery and to aid in the placement of depth electrode.
Device Description
Not Found
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K Number
K993622Device Name
NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY
Manufacturer
ALPHA OMEGA LTD.
Date Cleared
2000-01-24
(90 days)
Product Code
GZL
Regulation Number
882.1330Why did this record match?
Applicant Name (Manufacturer) :
ALPHA OMEGA LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Alpha Omega NeuroTrek system is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons to aid in the placement of depth electrode.
Device Description
The NeuroTrek is a physiological navigation system designed for clinical use during Pallidotomy or Thalamotomy and other neurosurgical procedures to assist in optimal target localization.
During surgery, a microelectrode is advanced into the brain with on-line recording and stimulation performed for precise focusing on the target organ and for evaluating the symptoms before and after. The physiological navigation and localization during the procedure is done for achieving better clinical results (short and long term). "On line" assessment of the electrophysiological activity assures the doctors that they are not about to cause irreversible damage to adjacent centers (i.e. Vision, Somatosensory), and allows confirmation of the target structure position.
The NeuroTrek system also enables design boundaries of target and localization of part position of the target for lesioning and electrode implantation.
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