Nelli Version 7.11
510(k) K251506
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK251506 | Date21 Nov 2025 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- POS
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1580
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Nelli Version 7.11 is a Physiological Signal-Based Seizure Monitoring System, designed to capture and analyze patient data for seizure detection. It integrates video and audio recordings from a Personal Recording Unit (PRU) to provide comprehensive monitoring of neurological events. The system employs machine learning algorithms to identify relevant moments, generating an interactive report for physician review. This aids in the assessment and management of epilepsy and related seizure disorders.
Nelli Version 7.11 is supplied as a reusable system with a web-based dashboard for viewing analysis results. The device operates under FDA 510(k) clearance and MDD authorization, adhering to regulatory standards for neurological monitoring equipment. It is intended for use in clinical settings, where it supports neurologists in evaluating seizure activity through continuous, multi-modal data collection. Storage and handling follow manufacturer guidelines to ensure device functionality and data integrity.
Other devices from Neuro Event Labs Oy
Questions
AI-generated answers, 18 Sep 2026
What types of data does the Nelli Version 7.11 system collect to detect seizures, and how does it combine them for analysis?
The Nelli Version 7.11 integrates physiological signals with video and audio recordings from its Personal Recording Unit (PRU) to monitor neurological events. It uses machine learning algorithms to analyze these multi-modal data streams—including patient-specific physiological metrics and behavioral cues—to identify relevant seizure moments. The system then generates an interactive report for physician review, enabling comprehensive assessment of epilepsy and seizure disorders.
Is the Nelli system reusable, and if so, what maintenance or handling guidelines should be followed to ensure proper functionality?
Yes, the Nelli Version 7.11 is designed as a reusable system. To maintain functionality and data integrity, it must be stored and handled according to the manufacturer’s guidelines, which likely include regular software updates, hardware inspections, and adherence to environmental conditions specified by Neuro Event Labs Oy. Proper maintenance ensures the system’s reliability for continuous seizure monitoring in clinical settings.
How does a clinician access and review the analysis results generated by the Nelli system?
Clinicians access and review analysis results through the Nelli system’s web-based dashboard. This platform provides an interactive report summarizing detected seizure events, combining physiological data, video, and audio recordings. The dashboard is designed to support neurologists in evaluating seizure activity and making informed decisions about patient management.
What regulatory pathways does the Nelli Version 7.11 follow, and how does this impact its use in clinical settings?
The Nelli Version 7.11 is cleared under the FDA’s 510(k) pathway and authorized under the MDD (Medical Device Directive). This regulatory status confirms its compliance with safety and performance standards for physiological signal-based seizure monitoring systems, ensuring its use is validated for clinical settings where neurologists rely on it to assess epilepsy and related disorders.