# K112077: Hbidb - Human Brian Index Software

- Pathway: 510(k) (Traditional)
- Applicant: Corscience GmbH & Co. KG
- Decided: Mar 9, 2012 after 232 days
- Product code: OLU (Normalizing Quantitative Electroencephalograph Software)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K801604 (1980). 18 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050192: BRC Software Product, Brc Operations Pty Limited (2005) Summary page 2.
- K041263: Neuroguide Analysis System, Applied Neuroscience, Inc. (2004) Summary page 2.
- K010669: Neurograph Evoked Potential Systems (Eps), Model Eps-1, Thuris Corp. (2001) Summary page 2.
- K974748: Neurometric Analysis System, Nxlink, Ltd. (1998) Summary page 4.

## Most influential descendants
- K121119: Bna Analysis System (2014), 2 descendants of its own
- K202588: BNA Platform (2020), 1 descendant of its own
- K253015: Cognitive Function Neuroimaging (cfNI) Software (1.0.0) (2026), 0 descendants of its own

## Indications for use
The HBlcdb product is to be used by qualified medical professionals for the post-hoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP).

Source page: https://510kreport.com/device/K112077
Methodology: https://510kreport.com/methodology