Cognitrace
FDA 510(k) K051825 · Eemagine Medical Imaging Solutions GmbH
510(k) numberK051825
Submission
- Device name
- Cognitrace
- Applicant
- Eemagine Medical Imaging Solutions GmbH
Deer Field, IL, US - Received
- July 5, 2005
- Decision date
- September 12, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GWQ – Full-Montage Standard Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
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
Other 510(k)s with product code GWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261604 | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)GWQ · Special | Neuroelectrics Barcelona S.L.U. | 06/13/2026SE |
| K260455 | New Wave SystemGWQ · Special | Zeto, Inc. | 03/13/2026SE |
| K233403 | Flexset SystemGWQ · Traditional | Zeto, Inc. | 04/30/2024SE |
| K231366 | Neuronaute PlusGWQ · Traditional | Bioserenity Sas | 11/09/2023SE |
| K221959 | Q21GWQ · Traditional | Neurofield, Inc. | 08/31/2023SE |
| K231457 | SPARK ScanGWQ · Traditional | Spark Neuro, Inc. | 08/18/2023SE |
| K221963 | Cumulus Functional Neurophysiology PlatformGWQ · Traditional | Cumulus Neuroscience Limited | 04/27/2023SE |
| K230073 | OktiGWQ · Traditional | Compumedics Limited | 02/09/2023SE |
| K223644 | Neuronaute with IceCap 2 & IceCap 2 SmallGWQ · Special | Bioserenity | 01/12/2023SE |
| K220056 | iSyncWaveGWQ · Traditional | iMediSync, Inc. | 08/10/2022SE |
More from iMediSync, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K240575 | WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)GXY · Traditional | 11/25/2024SE |
| K210109 | visor2 systemHAW · Traditional | 04/08/2022SE |
| K192889 | NeoOMA · Traditional | 01/30/2020SE |
| K172312 | eego amplifiersGWL · Traditional | 03/30/2018SE |
| K110223 | Waveguard (TM) EEG CapGXY · Traditional | 06/29/2011SE |
| K070358 | MaxinsightOLX · Traditional | 07/30/2007SE |
| K002631 | Electroencephalograph Software Eemagine EEGOLX · Traditional | 10/23/2000SE |
Questions and answers
When was Cognitrace cleared by the FDA?
Cognitrace (K051825) received a 510(k) decision of Substantially Equivalent on September 12, 2005, 69 days after the submission was received.
What is the product code of K051825?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.