# K082886: Zoom-100DC

- Pathway: 510(k) (Traditional)
- Applicant: Brainscope Company, Inc.
- Decided: Aug 10, 2009 after 314 days
- Product code: OLT (Non-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: 6 generations back to K963644 (1996). 23 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991054: Bravo Multi-Modality System, Nicolet Biomedical, Inc. (1999) Summary page 1.
- K970672: Crystal-Eeg Model 10 (Model 10), Cleveland Medical Devices, Inc. (1997) Summary page 1.
- K071449: BRM3 Brain Monitor, Brainz Instruments, Ltd. (2007) Summary page 1.
- K072382: Model I-2000 Monitor, Infinite Biomedical Technologies (2008) Summary page 1.

## Most influential descendants
- K092477: NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 (2010), 6 descendants of its own
- K142834: DiscoverEEG System, Model DE-401 (2015), 5 descendants of its own
- K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P (2012), 5 descendants of its own
- K213299: Wireless EEG System (2022), 2 descendants of its own
- K192549: Byteflies Kit (2020), 1 descendant of its own

## Indications for use
The ZOOM-100DC is used to measure and record the electrical activity of a patient's brain. The ZOOM-100DC is intended to monitor the state of the brain by acquisition and display of electroencephalogram (EEG) signals and by the calculation of standard quantitative EEG (qEEG) parameters.

Source page: https://510kreport.com/device/K082886
Methodology: https://510kreport.com/methodology