HZI CEEG/EP System Software (CEEG-Scan)
510(k) K863783
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK863783 | Date3 Mar 1987 | 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- Withdrawn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
- Full name
- Hzi Ceeg/Ep System Software (Ceeg-Scan)Tm
- 510(k) Number
- FDA Product Code
- OLT
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1400
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The HZI CEEG/EP System Software (CEEG-Scan) is a Non-Normalizing Quantitative Electroencephalograph Software, designed for the analysis and interpretation of electroencephalogram (EEG) and evoked potential (EP) data. It processes raw EEG signals to generate quantitative metrics, aiding in the assessment of brain function and neurological activity for clinical or research applications.
This software is supplied as a digital product for use on compatible computing systems and requires no physical sterilisation or single-use considerations. It operates within the regulatory framework of FDA 510(k) clearance (K863783), classified under product code OLT and authorised for neurology applications. No MRI safety or physical size specifications are noted, and storage is managed via standard IT protocols for medical software.
Questions
AI-generated answers, 20 Sep 2026
What clinical applications is the HZI CEEG/EP System Software designed to support?
The HZI CEEG/EP System Software is specifically designed for the analysis and interpretation of electroencephalogram (EEG) and evoked potential (EP) data. It aids in assessing brain function and neurological activity, making it useful for clinical neurology applications such as monitoring brain activity, diagnosing neurological disorders, or conducting research involving EEG/EP metrics.
How is the HZI CEEG/EP System Software supplied and does it require physical sterilization?
The software is supplied as a digital product for use on compatible computing systems. Since it is not a physical device, there are no requirements for physical sterilization or single-use considerations. It operates entirely through standard IT protocols for medical software.
Is this software compatible with MRI environments, and if not, why?
The provided data does not mention MRI safety specifications for the HZI CEEG/EP System Software. As a digital product, it does not contain physical components that would interact with MRI environments, but users should confirm compatibility with their specific MRI systems and protocols to ensure no interference or safety risks.
What regulatory pathway was followed for FDA clearance of this software?
The HZI CEEG/EP System Software received FDA clearance through a Traditional 510(k) process, classified under product code OLT and authorized for neurology applications. The submission was reviewed by the Neurology (NE) Advisory Committee and determined to be Substantially Equivalent (SESE) to a predicate device, with clearance granted on March 3, 1987.
How should the software be stored, and are there any special considerations for its maintenance?
Since the software is a digital product, storage follows standard IT protocols for medical software. This includes secure digital storage systems, regular software updates, and compliance with institutional IT policies to ensure data integrity and accessibility. No physical storage requirements (e.g., temperature, humidity) apply, but proper backup and cybersecurity measures are essential for clinical use.