Neurosearch-24 or Nrs-24
by Lexicor Medical Technology, Inc. 2 variants
510(k) K904269
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904269 | Date4 Jun 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GWQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1400
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The NeuroSearch-24 (NRS-24) is a Full-Montage Standard Electroencephalograph, a diagnostic device used to record and analyze electrical activity in the brain. It provides a 24-channel system for capturing continuous EEG waveforms, enabling clinicians to monitor brain function for conditions such as epilepsy, sleep disorders, or neurological abnormalities. The device facilitates precise, objective, and consistent assessment of brain activity patterns through standardized electrode placement and signal amplification.
The NRS-24 is supplied as a reusable medical device intended for use in clinical settings such as hospitals, neurology clinics, or sleep laboratories. It is not described as sterile but must be cleaned and maintained according to manufacturer guidelines to ensure accurate and reliable performance. The device is classified as Class II under FDA regulations (21 CFR 882.1400) and holds a 510(k) clearance (K904269) for substantial equivalence in neurology applications. Additional regulatory filings (e.g., K915820) reflect further clearance updates, though only the original 510(k) is explicitly referenced in the specifications.
Other devices from Lexicor Medical Technology, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the NeuroSearch-24 (NRS-24) used for?
The NeuroSearch-24 (NRS-24) is a full-montage standard electroencephalograph designed to record and analyze electrical brain activity. Clinicians use it to diagnose and monitor conditions such as epilepsy, sleep disorders, and neurological abnormalities by capturing continuous 24-channel EEG waveforms. Its standardized electrode placement ensures consistent and objective assessment of brain function patterns.
Is the NeuroSearch-24 (NRS-24) a single-use or reusable device?
The NeuroSearch-24 (NRS-24) is a reusable medical device intended for use in clinical settings like hospitals, neurology clinics, and sleep laboratories. While it is not sterile, it must be cleaned and maintained according to manufacturer guidelines to ensure accurate performance and reliability over repeated use.
What regulatory approvals does the NeuroSearch-24 (NRS-24) hold?
The NeuroSearch-24 (NRS-24) holds FDA 510(k) clearance (K904269) for substantial equivalence in neurology applications. It is classified as a Class II device under FDA regulations (21 CFR 882.1400), reflecting its role in diagnostic electroencephalography. Additional filings (e.g., K915820) address further updates but do not alter the original clearance.
How is the NeuroSearch-24 (NRS-24) supplied and stored?
The device is supplied as a reusable system for clinical environments. Since it is not sterile, proper cleaning and maintenance are required between uses to prevent contamination and ensure functionality. Storage should follow manufacturer instructions to preserve its technical integrity, including protection from environmental factors like moisture or extreme temperatures.
Does the NeuroSearch-24 (NRS-24) support multiple electrode configurations?
The NeuroSearch-24 (NRS-24) is a 24-channel EEG device, meaning it is designed for standardized electrode placement to capture comprehensive brain activity data. While it adheres to full-montage configurations, its fixed channel count ensures consistency in monitoring neurological conditions without requiring additional hardware for varied setups.