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510(k) Data Aggregation
K Number
K182700Device Name
Nexstim Navigated Brain Therapy (NBT) System 2
Manufacturer
Nexstim Plc
Date Cleared
2019-03-22
(176 days)
Product Code
OBP, GWF, HAW, IKN
Regulation Number
882.5805Why did this record match?
Applicant Name (Manufacturer) :
Nexstim Plc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nexstim Navigated Brain Therapy (NBT®) System 2 is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Device Description
The Nexstim Navigated Brain Therapy (NBT®) System is a non-invasive, repetitive transcranial magnetic stimulation (rTMS) system that delivers repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder (MDD) without inducing seizure in patients who have failed one (1) antidepressant medication.
The Nexstim NBT System 2 is used for patient treatment by prescription only and must be operated by a trained medical professional. It can be used in both inpatient and outpatient settings including physician's offices and clinics, psychiatric hospitals, and general medical/surgical hospitals with psychiatric units.
The Nexstim NBT System 2 consists of a group of devices designed to localize the stimulation site in the brain and deliver rTMS stimulation using controlling and interpretive software. Operational control of the Nexstim NBT System 2 is provided by the software.
The Nexstim NBT System 2 combines magnetic resonance imaging-based (MRI-based), three dimensional (3D) localization of cortical motor areas of the brain with non-invasive TMS and simultaneous electromyography (EMG) measurement to locate areas of the brain that are capable of evoking muscle responses when stimulated, and to locate the target area for depression therapy.
The Nexstim NBT System 2 software is used to import a patient's MR image slices to generate an accurate 3D model of the patient's head which can be electronically peeled back to reveal the anatomical structures of the brain.
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K Number
K171902Device Name
Nexstim Navigated Brain Therapy (NBT) System 2
Manufacturer
Nexstim Plc
Date Cleared
2017-11-10
(137 days)
Product Code
OBP, GWF, HAW, IKN
Regulation Number
882.5805Why did this record match?
Applicant Name (Manufacturer) :
Nexstim Plc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nexstim Navigated Brain Therapy (NBT®) System 2 is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Device Description
The Nexstim NBT® System 2 is a repetitive transcranial magnetic stimulation (rTMS) system that delivers repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder (MDD) without inducing seizure in patients who have failed one antidepressant medication.
The Nexstim NBT System 2 is used for patient treatment by prescription only and must be operated by a trained medical professional. It can be used in both inpatient and outpatient settings including physician's offices and clinics, psychiatric hospitals, and general medical/surgical hospitals with psychiatric units.
The Nexstim NBT System 2 consists of a group of devices designed to localize the stimulation site in the brain and deliver rTMS stimulation using controlling and interpretive software. Operational control of the Nexstim NBT System 2 is provided by the software.
The Nexstim NBT System 2 combines magnetic resonance imaging-based (MRI-based), three-dimensional (3-D) localization of cortical motor areas of the brain with non-invasive TMS and simultaneous electromyography (EMG) measurement to locate areas of the brain that are capable of evoking muscle responses when stimulated, and to locate the target area for depression therapy.
The Nexstim NBT System 2 software is used to import a patient's MR image slices through standard DICOM communication protocols, and generates an accurate 3-D model of the patient's head which can be "peeled back" to reveal the anatomical structures of the brain.
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