NeuroMatch
FDA 510(k) clearance K250239 · decided 2025-05-23
Clearance details
- K-number
- K250239
- Device name
- NeuroMatch
- Applicant
- LVIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2025-01-27
- Decision date
- 2025-05-23
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- OLX
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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| GEOSOURCE (K092844) | Electrical Geodesics, Inc. | 2010-12-21 |
| STELLATE GRIDVIEW (K100126) | Excel-Tech Ltd. (Xltek) | 2010-12-03 |
| ELEKTA NEUROMAG WITH MAXFILTER (K091393) | Elekta Neuromag OY | 2010-10-26 |
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| MAXINSIGHT (K070358) | Eemagine Medical Imaging Solutions GmbH | 2007-07-30 |
| ELEKTA NEUROMAG WITH MAXWELL FILTER (K050035) | Elekta Neuromag OY | 2005-01-25 |
Recalls involving this device
No recalls on record reference this clearance.