# K050192: BRC Software Product

- Pathway: 510(k) (Traditional)
- Applicant: Brc Operations Pty Limited
- Decided: Oct 20, 2005 after 266 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: 3 generations back to K801604 (1980). 17 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K974748: Neurometric Analysis System, Nxlink, Ltd. (1998) Summary page 1.
- K010669: Neurograph Evoked Potential Systems (Eps), Model Eps-1, Thuris Corp. (2001) Summary page 1.
- K041263: Neuroguide Analysis System, Applied Neuroscience, Inc. (2004) Summary page 1.

## Most influential descendants
- K112077: Hbidb - Human Brian Index Software (2012), 3 descendants of its own
- 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 BRC software 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/K050192
Methodology: https://510kreport.com/methodology