OLXClass II
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
21 CFR 882.1400 / Neurology
OLX is the FDA product code for Source Localization Software For Electroencephalograph Or Magnetoencephalograph, a class II device type, regulated under 21 CFR 882.1400. FDA's definition for this code reads: "Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization". As of , FDA records hold 25 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OLX
- Device name
- Source Localization Software For Electroencephalograph Or Magnetoencephalograph
- FDA definition
- Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization
- Regulation
- 21 CFR 882.1400
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 25
- Ingested recalls
- 0
Clearances, product code OLX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1996 | 1 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 2 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2010 | 3 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 2 |
Applicants with the most clearances
Product code OLX| Applicant | Clearances |
|---|---|
| Elekta Neuromag Oy | 4 |
| Biomagnetic Technologies, Inc. | 3 |
| Eemagine Medical Imaging Solutions GmbH | 2 |
| Neurosoft Ltd | 2 |
| Brain Electrophysiology Laboratory Company, LLC | 1 |
| Clouds of Care NV | 1 |
| Ctf Systems (2001), Inc. | 1 |
| Eagle Technology, Inc. | 1 |
| Electrical Geodesics, Inc. | 1 |
| Epilog | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
