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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
GXW
Echoencephalograph
2
Product Code
GXX
Block, Test, Ultrasonic Scanner Calibration
1
Product Code
GXY
Electrode, Cutaneous
2
Product Code
GXZ
Electrode, Needle
2
Product Code
GYA
Tester, Electrode/Lead, Electroencephalograph
1
Product Code
GXS
Monitor, Alpha
2
Product Code
GWE
Stimulator, Photic, Evoked Response
2
Product Code
GWF
Stimulator, Electrical, Evoked Response
2
Product Code
GWG
Endoscope, Neurological
2
Product Code
GWI
Discriminator, Two-Point
1
Product Code
GWJ
Stimulator, Auditory, Evoked Response
2
Product Code
GWK
Conditioner, Signal, Physiological
2
Product Code
GWL
Amplifier, Physiological Signal
2
Product Code
GWM
Device, Monitoring, Intracranial Pressure
2
Product Code
GWN
Nystagmograph
2
Product Code
GWQ
Full-Montage Standard Electroencephalograph
2
Product Code
GWR
Generator, Electroencephalograph Test Signal
1
Product Code
GWS
Analyzer, Spectrum, Electroencephalogram Signal
1
Product Code
GWW
Ataxiagraph
1
Product Code
GWX
Fork, Tuning
1
Product Code
GWY
Pinwheel
1
Product Code
GWZ
Percussor
1
Product Code
GXB
Esthesiometer
1
Product Code
GYB
Media, Electroconductive
2
Product Code
GYC
Electrode, Cortical
2
Product Code
GYD
Transducer, Tremor
2
Product Code
GYE
Encephalogram Telemetry System
2
Product Code
GZK
Electrode, Nasopharyngeal
2
Product Code
GZL
Electrode, Depth
2
Product Code
K
22
3269
Spencer Probe Depth Electrodes
2
Cleared 510(K)
K
22
3276
Anchor Bolts as Accessories to Depth Electrodes
2
Cleared 510(K)
K
21
3170
SENSOSEEG Depth Electrodes
2
Cleared 510(K)
K
22
2706
iCE-SG2 Subcutaneous Electrode Kit
2
Cleared 510(K)
K
22
2404
Evo® sEEG System
2
Cleared 510(K)
K
22
0553
Neuro Omega System, NeuroSmart System
2
Cleared 510(K)
K
20
2087
DIXI Medical Microdeep Micro-Macro Depth Electrodes
2
Cleared 510(K)
K
21
1367
Evo sEEG System
2
Cleared 510(K)
K
20
1678
iCE-SG Subcutaneous Electrode Arrays
2
Cleared 510(K)
K
19
1739
Sterile LeadConfirm
2
Cleared 510(K)
K
18
3123
microTargeting Guideline 4000 5.0 System
2
Cleared 510(K)
K
18
1544
Anchor Bolt (as an accessory to Depth Electrodes)
2
Cleared 510(K)
K
17
2042
NeuroNav System, NeuroSmart System
2
Cleared 510(K)
K
17
1581
Neuro Omega System
2
Cleared 510(K)
K
17
0959
DIXI Medical Microdeep Depth Electrode
2
Cleared 510(K)
K
16
2459
AccuPoint Electrode
2
Cleared 510(K)
K
16
3355
Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
2
Cleared 510(K)
K
15
1790
PMT Platinum Depthalon Depth Electrode
2
Cleared 510(K)
K
15
2547
DNAP Electrode
2
Cleared 510(K)
K
14
0680
LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM
2
Cleared 510(K)
K
12
3796
NEURO OMEGA SYSTEM
2
Cleared 510(K)
K
12
0098
STERILE DISPOSABLES FOR MER
2
Cleared 510(K)
K
11
0010
NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM
2
Cleared 510(K)
K
08
2404
NAVIGATION PROBES
2
Cleared 510(K)
K
07
1697
NEURONAV SYSTEM AND NEURONAV DRIVE
2
Cleared 510(K)
K
07
0272
NEUROPORT ELECTRODE
2
Cleared 510(K)
K
07
1364
MICROTARGETING GUIDELINE 4000
2
Cleared 510(K)
K
05
3358
DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
2
Cleared 510(K)
K
05
2527
NEUROPROBES
2
Cleared 510(K)
K
05
1830
NEURODRIVE SYSTEM
2
Cleared 510(K)
K
04
2384
NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
2
Cleared 510(K)
K
04
2208
ISIS MER SYSTEM/ELEKTA MER SYSTEM
2
Cleared 510(K)
K
04
1409
MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799
2
Cleared 510(K)
K
04
1604
MACRO-MICRO DEPTH ELECTRODE
2
Cleared 510(K)
K
03
3730
PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES
2
Cleared 510(K)
K
03
3173
MICRO TARGETING ELECTRODE
2
Cleared 510(K)
K
01
2850
RECORDING AND STIMULATING ELECTRODE
2
Cleared 510(K)
K
99
1522
MICROTARGETING ELECTRODE
2
Cleared 510(K)
K
99
3622
NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY
2
Cleared 510(K)
K
99
0788
AD-TECH'S FORAMEN OVALE ELECTRODE
2
Cleared 510(K)
K
99
1077
MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)
2
Cleared 510(K)
K
98
1820
NEUROMAP
2
Cleared 510(K)
K
98
1015
PALI-TRODE
2
Cleared 510(K)
K
97
3454
AD-TECH'S SPINAL ELECTRODE
2
Cleared 510(K)
K
97
0943
GUIDELINE SYSTEM
2
Cleared 510(K)
K
96
4644
AD-TECH'S DEPTH ELECTRODE
2
Cleared 510(K)
K
97
0418
PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)
2
Cleared 510(K)
K
94
6018
TENS-IT, FITTRONIC II, (MORE LATER)
2
Cleared 510(K)
K
94
4061
CUEVA CRANIAL NERVE ELECTRODE
2
Cleared 510(K)
K
90
2976
MEDI MODEL SBL502-B (LISS BODY STIMULATOR) ZERO DC
2
Cleared 510(K)
K
89
1920
AD-TECH'S DEPTH ELECTRODE
2
Cleared 510(K)
K
86
1031
WYLER SPHENOIDAL ELECTRODE
2
Cleared 510(K)
K
80
2249
MICROLET FAMILY OF NEEDLE/DEPTH ELECT-
2
Cleared 510(K)
K
80
2152
PMT DEPTHALON DEPTH #2102
2
Cleared 510(K)
K
80
2151
PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC
2
Cleared 510(K)
GZM
Analyzer, Rigidity
2
Product Code
GZN
Rheoencephalograph
3
Product Code
GZO
Device, Galvanic Skin Response Measurement
2
Product Code
GZP
Stimulator, Mechanical, Evoked Response
2
Product Code
HCJ
Device, Skin Potential Measurement
2
Product Code
HCS
Device, Temperature Measurement, Direct Contact, Powered
2
Product Code
JXE
Device, Nerve Conduction Velocity Measurement
2
Product Code
JXF
Plethysmograph, Ocular
3
Product Code
LLN
Device, Vibration Threshold Measurement
1
Product Code
LQW
Test, Temperature Discrimination
1
Product Code
NCG
Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
2
Product Code
NTU
Evoked Potential Stimulator, Thermal
2
Product Code
OLT
Non-Normalizing Quantitative Electroencephalograph Software
2
Product Code
OLU
Normalizing Quantitative Electroencephalograph Software
2
Product Code
OLV
Standard Polysomnograph With Electroencephalograph
2
Product Code
OLW
Index-Generating Electroencephalograph Software
2
Product Code
OLX
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
2
Product Code
OLY
Magnetoencephalograph
2
Product Code
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
2
Product Code
OMA
Amplitude-Integrated Electroencephalograph
2
Product Code
OMB
Automatic Event Detection Software For Full-Montage Electroencephalograph
2
Product Code
OMC
Reduced- Montage Standard Electroencephalograph
2
Product Code
ORT
Burst Suppression Detection Software For Electroencephalograph
2
Product Code
PIW
Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
2
Product Code
PKQ
Computerized Cognitive Assessment Aid
2
Product Code
PNA
Evoked Photon Image Capture Device
1
Product Code
POM
Computerized Cognitive Assessment Aid For Concussion
2
Product Code
POP
Cranial Motion Measurement Device
2
Product Code
POS
Physiological Signal Based Seizure Monitoring System
2
Product Code
PSP
Intracranial Pressure & Temperature Monitoring Kit
2
Product Code
PTB
Ataxiagraph With Interpretive Software
1
Product Code
PTY
Computerized Cognitive Assessment Aid, Exempt
2
Product Code
PVP
Neurological Test Kit
1
Product Code
QEA
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
2
Product Code
QPF
Pediatric Autism Spectrum Disorder Diagnosis Aid
2
Product Code
OPT
Infrared Hematoma Detector
2
Product Code
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
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 16 August 2024 at 11:05 pm
NE
/
subpart-b—neurological-diagnostic-devices
/
GZL
/
K172042
View Source
NeuroNav System, NeuroSmart System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172042
510(k) Type
Traditional
Applicant
Alpha Omega Engineering Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
2/27/2018
Days to Decision
236 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
GXW
Echoencephalograph
GXX
Block, Test, Ultrasonic Scanner Calibration
GXY
Electrode, Cutaneous
GXZ
Electrode, Needle
GYA
Tester, Electrode/Lead, Electroencephalograph
GXS
Monitor, Alpha
GWE
Stimulator, Photic, Evoked Response
GWF
Stimulator, Electrical, Evoked Response
GWG
Endoscope, Neurological
GWI
Discriminator, Two-Point
GWJ
Stimulator, Auditory, Evoked Response
GWK
Conditioner, Signal, Physiological
GWL
Amplifier, Physiological Signal
GWM
Device, Monitoring, Intracranial Pressure
GWN
Nystagmograph
GWQ
Full-Montage Standard Electroencephalograph
GWR
Generator, Electroencephalograph Test Signal
GWS
Analyzer, Spectrum, Electroencephalogram Signal
GWW
Ataxiagraph
GWX
Fork, Tuning
GWY
Pinwheel
GWZ
Percussor
GXB
Esthesiometer
GYB
Media, Electroconductive
GYC
Electrode, Cortical
GYD
Transducer, Tremor
GYE
Encephalogram Telemetry System
GZK
Electrode, Nasopharyngeal
GZL
Electrode, Depth
K
22
3269
Spencer Probe Depth Electrodes
K
22
3276
Anchor Bolts as Accessories to Depth Electrodes
K
21
3170
SENSOSEEG Depth Electrodes
K
22
2706
iCE-SG2 Subcutaneous Electrode Kit
K
22
2404
Evo® sEEG System
K
22
0553
Neuro Omega System, NeuroSmart System
K
20
2087
DIXI Medical Microdeep Micro-Macro Depth Electrodes
K
21
1367
Evo sEEG System
K
20
1678
iCE-SG Subcutaneous Electrode Arrays
K
19
1739
Sterile LeadConfirm
K
18
3123
microTargeting Guideline 4000 5.0 System
K
18
1544
Anchor Bolt (as an accessory to Depth Electrodes)
K
17
2042
NeuroNav System, NeuroSmart System
K
17
1581
Neuro Omega System
K
17
0959
DIXI Medical Microdeep Depth Electrode
K
16
2459
AccuPoint Electrode
K
16
3355
Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
K
15
1790
PMT Platinum Depthalon Depth Electrode
K
15
2547
DNAP Electrode
K
14
0680
LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM
K
12
3796
NEURO OMEGA SYSTEM
K
12
0098
STERILE DISPOSABLES FOR MER
K
11
0010
NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM
K
08
2404
NAVIGATION PROBES
K
07
1697
NEURONAV SYSTEM AND NEURONAV DRIVE
K
07
0272
NEUROPORT ELECTRODE
K
07
1364
MICROTARGETING GUIDELINE 4000
K
05
3358
DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
K
05
2527
NEUROPROBES
K
05
1830
NEURODRIVE SYSTEM
K
04
2384
NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
K
04
2208
ISIS MER SYSTEM/ELEKTA MER SYSTEM
K
04
1409
MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799
K
04
1604
MACRO-MICRO DEPTH ELECTRODE
K
03
3730
PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES
K
03
3173
MICRO TARGETING ELECTRODE
K
01
2850
RECORDING AND STIMULATING ELECTRODE
K
99
1522
MICROTARGETING ELECTRODE
K
99
3622
NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY
K
99
0788
AD-TECH'S FORAMEN OVALE ELECTRODE
K
99
1077
MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)
K
98
1820
NEUROMAP
K
98
1015
PALI-TRODE
K
97
3454
AD-TECH'S SPINAL ELECTRODE
K
97
0943
GUIDELINE SYSTEM
K
96
4644
AD-TECH'S DEPTH ELECTRODE
K
97
0418
PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)
K
94
6018
TENS-IT, FITTRONIC II, (MORE LATER)
K
94
4061
CUEVA CRANIAL NERVE ELECTRODE
K
90
2976
MEDI MODEL SBL502-B (LISS BODY STIMULATOR) ZERO DC
K
89
1920
AD-TECH'S DEPTH ELECTRODE
K
86
1031
WYLER SPHENOIDAL ELECTRODE
K
80
2249
MICROLET FAMILY OF NEEDLE/DEPTH ELECT-
K
80
2152
PMT DEPTHALON DEPTH #2102
K
80
2151
PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC
GZM
Analyzer, Rigidity
GZN
Rheoencephalograph
GZO
Device, Galvanic Skin Response Measurement
GZP
Stimulator, Mechanical, Evoked Response
HCJ
Device, Skin Potential Measurement
HCS
Device, Temperature Measurement, Direct Contact, Powered
JXE
Device, Nerve Conduction Velocity Measurement
JXF
Plethysmograph, Ocular
LLN
Device, Vibration Threshold Measurement
LQW
Test, Temperature Discrimination
NCG
Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
NTU
Evoked Potential Stimulator, Thermal
OLT
Non-Normalizing Quantitative Electroencephalograph Software
OLU
Normalizing Quantitative Electroencephalograph Software
OLV
Standard Polysomnograph With Electroencephalograph
OLW
Index-Generating Electroencephalograph Software
OLX
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
OLY
Magnetoencephalograph
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
OMA
Amplitude-Integrated Electroencephalograph
OMB
Automatic Event Detection Software For Full-Montage Electroencephalograph
OMC
Reduced- Montage Standard Electroencephalograph
ORT
Burst Suppression Detection Software For Electroencephalograph
PIW
Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
PKQ
Computerized Cognitive Assessment Aid
PNA
Evoked Photon Image Capture Device
POM
Computerized Cognitive Assessment Aid For Concussion
POP
Cranial Motion Measurement Device
POS
Physiological Signal Based Seizure Monitoring System
PSP
Intracranial Pressure & Temperature Monitoring Kit
PTB
Ataxiagraph With Interpretive Software
PTY
Computerized Cognitive Assessment Aid, Exempt
PVP
Neurological Test Kit
QEA
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
QPF
Pediatric Autism Spectrum Disorder Diagnosis Aid
OPT
Infrared Hematoma Detector
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
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-b—neurological-diagnostic-devices
/
GZL
/
K172042
View Source
NeuroNav System, NeuroSmart System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172042
510(k) Type
Traditional
Applicant
Alpha Omega Engineering Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
2/27/2018
Days to Decision
236 days
Submission Type
Summary