# K971329: CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem)

- Pathway: 510(k) (Traditional)
- Applicant: Ctf Systems, Inc.
- Decided: Nov 20, 1997 after 224 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- 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: 2 generations back to K901215 (1990). 2 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962764: Neuromag-122, Philips Medical Systems (Cleveland), Inc. (1996) Summary page 2.
- K901215: 700 Series Biomagnetometer, Biomagnetic Technologies, Inc. (1990) Summary page 2.

## Most influential descendants
- K030737: Omega Whole-Cortex MFG System, Models Omega 151, Omega 275 (2003), 10 descendants of its own
- K041264: Elekta OY (2004), 8 descendants of its own
- K050035: Elekta Neuromag with Maxwell Filter (2005), 4 descendants of its own
- K091393: Elekta Neuromag with Maxfilter (2010), 2 descendants of its own
- K233985: TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) (2024), 1 descendant of its own

## Indications for use
The CTF Systems Inc. "Whole-Cortex MEG System” non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic EEG signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain.* MEG is also ‘used to non-invasively locate regions of -epileptic-activity within—the'brain."The-localization information provided by MEG may be used, in conjunction with other diagunostic data, in neurosurgical planning. *when routinely used in conjunction wvith evoked response averaging devices

Source page: https://510kreport.com/device/K971329
Methodology: https://510kreport.com/methodology