Definition: Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization
| Device Type ID | 3769 |
| Device Name | Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Physical State | Software Algorithm. Does NOT Include Electrodes, Amplitude-integrated Electroencephalograph, Automatic Event-detection Software Used As The Only Or Final Electroencephalograph Analysis Step, Electroencephalograph Software With Comparative Databases ( |
| Technical Method | Uses Software Algorithms That Correlate The Electroencephalograph To One Or Several Types Of Neuroimaging Data. May Include Use Of Event-detection Algorithms (that Require User Confirmation) As An Intermediary, But Not Final, Step. |
| 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 | OLX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3769 |
| Device | Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Product Code | OLX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electroencephalograph. |
| CFR Regulation Number | 882.1400 [🔎] |
| Device Problems | |
|---|---|
Device Maintenance Issue | 1 |
| Total Device Problems | 1 |