# K981820: Neuromap

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Nov 20, 1998 after 182 days
- Product code: GZL (Electrode, Depth)
- Device class: 2
- Regulation: 21 CFR 882.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K993622: Neurotrek Physiological Navigation System for Neurosurgery (2000), 4 descendants of its own
- K071364: Microtargeting Guideline 4000 (2007), 3 descendants of its own
- K183123: microTargeting Guideline 4000 5.0 System (2018), 1 descendant of its own
- K250094: Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014) (2025), 0 descendants of its own
- K140680: Leadpoint Focus Workststion, Leadpoint Focus Notebook System (2014), 0 descendants of its own

## Indications for use
The Radionics, Inc. NeuroMap™ is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery. The system displays and stores electrophysiological activity of the CNS relayed from electrodes placed within the brain and on the surface of the skin. NeuroMap™ helps the neurosurgeons determine the location of certain brain structures before lesioning is performed by allowing them to examine and analyze the electrical signals.

Source page: https://510kreport.com/device/K981820
Methodology: https://510kreport.com/methodology