Definition: Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations
| Device Type ID | 3647 |
| Device Name | Full-montage Standard Electroencephalograph |
| Physical State | May Include Standard Electroencephalograph Recording Hardware (e.g. Headbox, Cables, Computer, Monitor, Wireless) And Basic Software (e.g. Used To Display, Store, Archive, Or Manually Annotate Data). Does NOT Include Electrodes, More Complex Software |
| Technical Method | Uses Electrodes (16 Or More) Placed On The Scalp Or Within The Brain, Via User-specified Locations, To Record And Display Electrical Activity Of The Brain |
| Target Area | Brain |
| Regulation Description | Electroencephalograph. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.1400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GWQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 3647 |
| Device | Full-montage Standard Electroencephalograph |
| Product Code | GWQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electroencephalograph. |
| CFR Regulation Number | 882.1400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BRAINMASTER TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CADWELL INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CAREFUSION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EXCEL-TECH LTD. (XLTEK) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIFELINES LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NATUS MEDICAL INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
NEUROVIRTUAL USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect Measurement | 26 |
Mechanical Problem | 9 |
Device Sensing Problem | 5 |
Sparking | 4 |
Device Operates Differently Than Expected | 3 |
Device Stops Intermittently | 3 |
Device Inoperable | 3 |
Power Problem | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Detachment Of Device Or Device Component | 3 |
Overheating Of Device | 2 |
Unable To Obtain Readings | 2 |
Misassembly By Users | 2 |
Use Of Device Problem | 2 |
Device Tipped Over | 2 |
Fire | 2 |
Failure To Sense | 1 |
Patient-Device Incompatibility | 1 |
Extender | 1 |
Vibration | 1 |
Material Integrity Problem | 1 |
Signal Artifact | 1 |
No Display / Image | 1 |
Device Handling Problem | 1 |
Material Separation | 1 |
Unintended Collision | 1 |
Peeled / Delaminated | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Unintended Movement | 1 |
Excessive Heating | 1 |
Component Falling | 1 |
Carrier | 1 |
Failure To Run On AC/DC | 1 |
Display Or Visual Feedback Problem | 1 |
| Total Device Problems | 92 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | II | Jul-28-2018 |
| 2 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | II | Jan-04-2016 |
| 3 | Natus Neurology Inc | II | Oct-13-2015 |