FDA Product Code
FDA Product Code OLX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1400
510(k) Clearances — 25 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260563 | CN-Suite | FIND Surgical Sciences Inc. D/B/A FIND Neuro | 2026-08-16 | Traditional | PDF ↗ |
| K252565 | PreOp v3 | Clouds of Care | 2026-02-13 | Special | PDF ↗ |
| K250239 | NeuroMatch | LVIS Corporation | 2025-05-23 | Traditional | PDF ↗ |
| K241513 | Sourcerer | Brain Electrophysiology Laboratory Company, LLC | 2024-09-27 | Traditional | PDF ↗ |
| K233985 | TRIUX neo (NM27000N ); MEGreview (SW26241N-B) | Megin OY | 2024-05-15 | Traditional | PDF ↗ |
| K210199 | RICOH MEG | Ricoh Company, Ltd. | 2021-07-02 | Traditional | PDF ↗ |
| K201910 | EZTrack | Neurologic, LLC | 2020-12-22 | Traditional | PDF ↗ |
| K172858 | PreOp | Epilog | 2018-01-08 | Traditional | PDF ↗ |
| K092844 | GEOSOURCE | Electrical Geodesics, Inc. | 2010-12-21 | Traditional | PDF ↗ |
| K100126 | STELLATE GRIDVIEW | Excel-Tech Ltd. (Xltek) | 2010-12-03 | Abbreviated | PDF ↗ |
| K091393 | ELEKTA NEUROMAG WITH MAXFILTER | Elekta Neuromag OY | 2010-10-26 | Traditional | PDF ↗ |
| K081430 | ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING | Elekta Neuromag OY | 2008-07-28 | Special | PDF ↗ |
| K070358 | MAXINSIGHT | Eemagine Medical Imaging Solutions GmbH | 2007-07-30 | Traditional | PDF ↗ |
| K050035 | ELEKTA NEUROMAG WITH MAXWELL FILTER | Elekta Neuromag OY | 2005-01-25 | Special | PDF ↗ |
| K041264 | ELEKTA OY | Elekta Neuromag OY | 2004-08-10 | Traditional | PDF ↗ |
| K040051 | MEGVISION, MODEL EQ1000C SERIES | Eagle Technology, Inc. | 2004-03-24 | Traditional | PDF ↗ |
| K030737 | OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 | Ctf Systems (2001), Inc. | 2003-10-10 | Special | PDF ↗ |
| K011241 | NEUROSOFT'S SOURCE | Neurosoft, Inc. | 2001-09-19 | Traditional | PDF ↗ |
| K001781 | CURRY MULTIMODAL NEUROIMAGING SOFTWARE | Neurosoft, Inc. | 2001-02-05 | Traditional | PDF ↗ |
| K002631 | ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG | Eemagine Medical Imaging Solutions GmbH | 2000-10-23 | Traditional | PDF ↗ |
| K993708 | BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG | Biomagnetic Technologies, Inc. | 1999-12-03 | Special | PDF ↗ |
| K984401 | NEUROMAG VECTORVIEW | Philips Medical Systems (Cleveland), Inc. | 1998-12-30 | Special | PDF ↗ |
| K980477 | IMAGE VUE EEG | Sam Technology, Inc. | 1998-08-06 | Traditional | PDF ↗ |
| K941553 | MAGNES II BIOMAGNETOMETER | Biomagnetic Technologies, Inc. | 1996-05-16 | Traditional | PDF ↗ |
| K901215 | 700 SERIES BIOMAGNETOMETER | Biomagnetic Technologies, Inc. | 1990-06-25 | Traditional | PDF ↗ |
Product code OLX · Class II · Neurology. Data: openFDA.