# K030737: Omega Whole-Cortex MFG System, Models Omega 151, Omega 275

- Pathway: 510(k) (Special)
- Applicant: Ctf Systems (2001), Inc.
- Decided: Oct 10, 2003 after 214 days
- Product code: OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph)
- 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 K901215 (1990). 3 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971329: CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem), Ctf Systems, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K260563: CN-Suite™ (2026), 0 descendants of its own

## Indications for use
The Omega 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 when used in conjunction with evoked response averaging devices. 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 diagnostic data, in neurosurgical planning.

Source page: https://510kreport.com/device/K030737
Methodology: https://510kreport.com/methodology