FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
GXO
Strip, Craniosynostosis, Preformed
2
Product Code
GXP
Methyl Methacrylate For Cranioplasty
2
Product Code
GXQ
Dura Substitute
2
Product Code
GXR
Cover, Burr Hole
2
Product Code
GXT
Monitor, Lesion Temperature
2
Product Code
GWO
Plate, Cranioplasty, Preformed, Alterable
2
Product Code
GXC
Device, Electroconvulsive Therapy
3
Product Code
GXN
Plate, Cranioplasty, Preformed, Non-Alterable
2
Product Code
GYZ
Stimulator, Intracerebral/Subcortical, Implanted
3
Product Code
GZA
Implanted Cerebellar Stimulator
3
Product Code
GZB
Stimulator, Spinal-Cord, Implanted (Pain Relief)
2
Product Code
GZF
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
2
Product Code
GZI
Stimulator, Neuromuscular, External Functional
2
Product Code
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
2
Product Code
HAX
Tong, Skull For Traction
2
Product Code
HBP
Clip, Implanted Malleable
2
Product Code
HBW
Fastener, Plate, Cranioplasty
2
Product Code
HBZ
Catheter, Intravascular Occluding
3
Product Code
HCB
Device, Aversive Conditioning
2
Product Code
HCC
Device, Biofeedback
2
Product Code
HCE
Clamp, Carotid Artery
2
Product Code
HCG
Device, Neurovascular Embolization
2
Product Code
HCH
Clip, Aneurysm
2
Product Code
JXG
Shunt, Central Nervous System And Components
2
Product Code
JXH
Methyl Methacrylate For Aneurysmorrhaphy
2
Product Code
JXI
Cuff, Nerve
2
Product Code
JXK
Cranial Electrotherapy Stimulator To Treat Depression
3
Product Code
JXL
Block, Bite
2
Product Code
LEL
Device, Sleep Assessment
2
Product Code
LHG
Electrode, Spinal Epidural
2
Product Code
LIH
Interferential Current Therapy
2
Product Code
MVA
Orthosis, Cranial
2
Product Code
MYU
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
2
Product Code
MZQ
Balloon, Detachable, For Neurovascular Occlusion
2
Product Code
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
2
Product Code
NHI
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
2
Product Code
NUF
Catheter, Neurovasculature, Occluding Balloon
3
Product Code
NUH
Stimulator, Nerve, Transcutaneous, Over-The-Counter
2
Product Code
NYN
Stimulator, Electrical, Transcutaneous, For Arthritis
2
Product Code
NYW
Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief
2
Product Code
NYX
Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes
2
Product Code
OAN
Orthosis, Cranial, Laser Scan
2
Product Code
OBP
Transcranial Magnetic Stimulator
2
Product Code
K
24
1518
Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)
2
Cleared 510(K)
K
22
2196
Deep TMS System
2
Cleared 510(K)
K
23
2639
Apollo TMS Therapy System
2
Cleared 510(K)
K
23
1926
NeuroStar Advanced Therapy System (All previously cleared models)
2
Cleared 510(K)
K
23
3631
ZapStim Controller Application (Z1023)
2
Cleared 510(K)
K
23
2688
NQ TMS for MDD (NQv1-MU-01)
2
Cleared 510(K)
K
23
3621
NeuroStar Advanced Therapy System (Version 3.8)
2
Cleared 510(K)
K
23
2235
Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro
2
Cleared 510(K)
K
23
0735
Ultimate rTMS; Yingchi rTMS
2
Cleared 510(K)
K
23
0029
NeuroStar Advanced Therapy System (Version 3.7)
2
Cleared 510(K)
K
22
3154
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
2
Cleared 510(K)
K
22
2171
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
2
Cleared 510(K)
K
22
0177
Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K
2
Cleared 510(K)
K
22
0819
BrainsWay Deep TMS System
2
Cleared 510(K)
K
22
2230
NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health
2
Cleared 510(K)
K
22
0127
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
2
Cleared 510(K)
K
22
0625
ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
2
Cleared 510(K)
K
21
2723
BTL-995-rTMS
2
Cleared 510(K)
K
21
3543
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
2
Cleared 510(K)
K
20
2537
ALTMS Magnetic Stimulation Therapy System
2
Cleared 510(K)
K
21
1389
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
2
Cleared 510(K)
K
21
0201
Deep Transcranial Magnetic Stimulation (DTMS) System
2
Cleared 510(K)
K
20
3735
Brainsway Deep TMS System
2
Cleared 510(K)
K
20
1158
NeuroStar Advanced Therapy
2
Cleared 510(K)
K
18
3376
HORIZON TMS Therapy System with Navigation
2
Cleared 510(K)
K
18
2700
Nexstim Navigated Brain Therapy (NBT) System 2
2
Cleared 510(K)
K
18
2853
HORIZON TMS Therapy System
2
Cleared 510(K)
K
17
3620
Mag Vita TMS Therapy System w/Theta Burst Stimulation
2
Cleared 510(K)
K
18
0907
HORIZON TMS Therapy System
2
Cleared 510(K)
K
18
0313
Apollo TMS Therapy System
2
Cleared 510(K)
K
17
3540
Brainsway Deep (DTMS) System
2
Cleared 510(K)
K
17
3441
Neurosoft TMS (also CloudTMS)
2
Cleared 510(K)
K
17
1902
Nexstim Navigated Brain Therapy (NBT) System 2
2
Cleared 510(K)
K
17
2667
MagVita TMS Therapy w/MagPro R20
2
Cleared 510(K)
K
17
1051
HORIZON Therapy System
2
Cleared 510(K)
K
17
1967
MagVita TMS Therapy System
2
Cleared 510(K)
K
17
1481
MagVita TMS Therapy System
2
Cleared 510(K)
K
17
0114
MagVita TMS Therapy - w/MagPro R20
2
Cleared 510(K)
K
16
2935
Rapid2 Therapy System
2
Cleared 510(K)
K
16
0309
Neurosoft TMS
2
Cleared 510(K)
K
16
1519
NeuroStar TMS Therapy System
2
Cleared 510(K)
K
16
0703
NeuroStar TMS Therapy System
2
Cleared 510(K)
K
15
0641
MagVita TMS Therapy System
2
Cleared 510(K)
K
14
3531
Rapid Therapy System
2
Cleared 510(K)
K
13
3408
NEUROSTAR TMS THERAPY SYSTEM
2
Cleared 510(K)
K
13
0233
NEUROSTAR TMS THERAPY SYSTEM
2
Cleared 510(K)
K
12
2288
BRAINSWAY DEEP TMS SYSTEM
2
Cleared 510(K)
K
08
3538
NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1
2
Cleared 510(K)
DEN
07
0003
NEUROSTAR TMS SYSTEM
2
Cleared 510(K)
OBV
Eating Disorder Conditioning Tool
2
Product Code
OCF
Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
2
Product Code
OKP
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
2
Product Code
QMD
Transcranial Magnetic Stimulation System For Smoking Cessation
2
Product Code
OSG
Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
2
Product Code
PAV
Catheter, Neuro-Vasculature, Occluding Balloon
F
Product Code
PBJ
Cranial Distraction System
2
Product Code
PCB
External Cerebrospinal Fluid (Csf) Diversion
2
Product Code
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
2
Product Code
PJM
Filler, Bone Void, Alterable Compound For Cranioplasty
2
Product Code
PJN
Filler, Bone Void, Non-Alterable Compound For Cranioplasty
2
Product Code
PKR
Non-Invasive Vagus Nerve Stimulator - Headache
2
Product Code
PLU
Thermal System For Insomnia
2
Product Code
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
2
Product Code
PUU
Temporary Coil Embolization Assist Device
2
Product Code
PVL
Endoscopic Shunt Placement Kit
2
Product Code
PVO
Lumbar Drainage Catheter Kit
2
Product Code
PWE
Computerized Behavioral Therapy Device For Psychiatric Disorders
2
Product Code
PZR
Percutaneous Nerve Stimulator For Opioid Withdrawal
2
Product Code
QAK
Non-Invasive Vagus Nerve Stimulator For Migraine Headache
2
Product Code
QAR
Thermal Vestibular Stimulator For Headache
2
Product Code
QBC
External Upper Limb Tremor Stimulator
2
Product Code
QCI
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
2
Product Code
QFD
Tens For Sinus Pain
2
Product Code
QFF
Electromechanical Arm For A Transcranial Magnetic Stimulation System
2
Product Code
QGH
Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
2
Product Code
QGL
Transcutaneous Nerve Stimulator For Adhd
2
Product Code
QGT
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
2
Product Code
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
2
Product Code
QMZ
Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
2
Product Code
QQC
Brain Stimulation Programming Planning Software.
2
Product Code
QFT
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
2
Product Code
OVP
Vibratory Counter-Stimulation
2
Product Code
QVO
Computerized Behavioral Therapy Device For Insomnia
2
Product Code
SAP
Computerized Behavioral Therapy Device For Depressive Disorders.
2
Product Code
SCP
Computerized Behavioral Therapy Device For Anxiety Disorders
2
Product Code
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 20 December 2024 at 11:05 pm
NE
/
subpart-f—neurological-therapeutic-devices
/
OBP
/
K160703
View Source
NeuroStar TMS Therapy System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160703
510(k) Type
Traditional
Applicant
NEURONETICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/10/2016
Days to Decision
88 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart B—Neurological Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
GXO
Strip, Craniosynostosis, Preformed
GXP
Methyl Methacrylate For Cranioplasty
GXQ
Dura Substitute
GXR
Cover, Burr Hole
GXT
Monitor, Lesion Temperature
GWO
Plate, Cranioplasty, Preformed, Alterable
GXC
Device, Electroconvulsive Therapy
GXN
Plate, Cranioplasty, Preformed, Non-Alterable
GYZ
Stimulator, Intracerebral/Subcortical, Implanted
GZA
Implanted Cerebellar Stimulator
GZB
Stimulator, Spinal-Cord, Implanted (Pain Relief)
GZF
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
GZI
Stimulator, Neuromuscular, External Functional
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
HAX
Tong, Skull For Traction
HBP
Clip, Implanted Malleable
HBW
Fastener, Plate, Cranioplasty
HBZ
Catheter, Intravascular Occluding
HCB
Device, Aversive Conditioning
HCC
Device, Biofeedback
HCE
Clamp, Carotid Artery
HCG
Device, Neurovascular Embolization
HCH
Clip, Aneurysm
JXG
Shunt, Central Nervous System And Components
JXH
Methyl Methacrylate For Aneurysmorrhaphy
JXI
Cuff, Nerve
JXK
Cranial Electrotherapy Stimulator To Treat Depression
JXL
Block, Bite
LEL
Device, Sleep Assessment
LHG
Electrode, Spinal Epidural
LIH
Interferential Current Therapy
MVA
Orthosis, Cranial
MYU
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
MZQ
Balloon, Detachable, For Neurovascular Occlusion
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
NHI
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
NUF
Catheter, Neurovasculature, Occluding Balloon
NUH
Stimulator, Nerve, Transcutaneous, Over-The-Counter
NYN
Stimulator, Electrical, Transcutaneous, For Arthritis
NYW
Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief
NYX
Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes
OAN
Orthosis, Cranial, Laser Scan
OBP
Transcranial Magnetic Stimulator
K
24
1518
Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)
K
22
2196
Deep TMS System
K
23
2639
Apollo TMS Therapy System
K
23
1926
NeuroStar Advanced Therapy System (All previously cleared models)
K
23
3631
ZapStim Controller Application (Z1023)
K
23
2688
NQ TMS for MDD (NQv1-MU-01)
K
23
3621
NeuroStar Advanced Therapy System (Version 3.8)
K
23
2235
Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro
K
23
0735
Ultimate rTMS; Yingchi rTMS
K
23
0029
NeuroStar Advanced Therapy System (Version 3.7)
K
22
3154
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
K
22
2171
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
K
22
0177
Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K
K
22
0819
BrainsWay Deep TMS System
K
22
2230
NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health
K
22
0127
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
K
22
0625
ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
K
21
2723
BTL-995-rTMS
K
21
3543
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
K
20
2537
ALTMS Magnetic Stimulation Therapy System
K
21
1389
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
K
21
0201
Deep Transcranial Magnetic Stimulation (DTMS) System
K
20
3735
Brainsway Deep TMS System
K
20
1158
NeuroStar Advanced Therapy
K
18
3376
HORIZON TMS Therapy System with Navigation
K
18
2700
Nexstim Navigated Brain Therapy (NBT) System 2
K
18
2853
HORIZON TMS Therapy System
K
17
3620
Mag Vita TMS Therapy System w/Theta Burst Stimulation
K
18
0907
HORIZON TMS Therapy System
K
18
0313
Apollo TMS Therapy System
K
17
3540
Brainsway Deep (DTMS) System
K
17
3441
Neurosoft TMS (also CloudTMS)
K
17
1902
Nexstim Navigated Brain Therapy (NBT) System 2
K
17
2667
MagVita TMS Therapy w/MagPro R20
K
17
1051
HORIZON Therapy System
K
17
1967
MagVita TMS Therapy System
K
17
1481
MagVita TMS Therapy System
K
17
0114
MagVita TMS Therapy - w/MagPro R20
K
16
2935
Rapid2 Therapy System
K
16
0309
Neurosoft TMS
K
16
1519
NeuroStar TMS Therapy System
K
16
0703
NeuroStar TMS Therapy System
K
15
0641
MagVita TMS Therapy System
K
14
3531
Rapid Therapy System
K
13
3408
NEUROSTAR TMS THERAPY SYSTEM
K
13
0233
NEUROSTAR TMS THERAPY SYSTEM
K
12
2288
BRAINSWAY DEEP TMS SYSTEM
K
08
3538
NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1
DEN
07
0003
NEUROSTAR TMS SYSTEM
OBV
Eating Disorder Conditioning Tool
OCF
Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
OKP
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
QMD
Transcranial Magnetic Stimulation System For Smoking Cessation
OSG
Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
PAV
Catheter, Neuro-Vasculature, Occluding Balloon
PBJ
Cranial Distraction System
PCB
External Cerebrospinal Fluid (Csf) Diversion
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
PJM
Filler, Bone Void, Alterable Compound For Cranioplasty
PJN
Filler, Bone Void, Non-Alterable Compound For Cranioplasty
PKR
Non-Invasive Vagus Nerve Stimulator - Headache
PLU
Thermal System For Insomnia
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
PUU
Temporary Coil Embolization Assist Device
PVL
Endoscopic Shunt Placement Kit
PVO
Lumbar Drainage Catheter Kit
PWE
Computerized Behavioral Therapy Device For Psychiatric Disorders
PZR
Percutaneous Nerve Stimulator For Opioid Withdrawal
QAK
Non-Invasive Vagus Nerve Stimulator For Migraine Headache
QAR
Thermal Vestibular Stimulator For Headache
QBC
External Upper Limb Tremor Stimulator
QCI
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
QFD
Tens For Sinus Pain
QFF
Electromechanical Arm For A Transcranial Magnetic Stimulation System
QGH
Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
QGL
Transcutaneous Nerve Stimulator For Adhd
QGT
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
QMZ
Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
QQC
Brain Stimulation Programming Planning Software.
QFT
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
OVP
Vibratory Counter-Stimulation
QVO
Computerized Behavioral Therapy Device For Insomnia
SAP
Computerized Behavioral Therapy Device For Depressive Disorders.
SCP
Computerized Behavioral Therapy Device For Anxiety Disorders
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
subpart-f—neurological-therapeutic-devices
/
OBP
/
K160703
View Source
NeuroStar TMS Therapy System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160703
510(k) Type
Traditional
Applicant
NEURONETICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/10/2016
Days to Decision
88 days
Submission Type
Summary