510(k) · Cleared
ClearedCTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ctf Systems, Inc. · GWQ Full-Montage Standard Electroencephalograph
Cleared on Nov 20, 1997 as substantially equivalent to K962764 (Philips Medical Systems (Cleveland), Inc., 1996) and 1 other predicate after a 224-day review. Its family tree reaches back 2 generations to 1990. 12 later devices descend from it.
- Decided
- Nov 20, 1997
- Review
- 224 days
- Class
- Class II
- Product code
- GWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K901215 (1990). 12 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK901215 700 Series BiomagnetometerBiomagnetic Technologies, Inc. · 1990
- 1 generation backK962764 Neuromag-122Philips Medical Systems (Cleveland), Inc. · 1996
- This deviceK971329 CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem)Ctf Systems, Inc. · 1997
- Descendant · cites it directly · 10 of its ownK030737 Omega Whole-Cortex MFG System, Models Omega 151, Omega 275Ctf Systems (2001), Inc. · 2003
- Descendant · 2 generations on · 8 of its ownK041264 Elekta OYElekta Neuromag OY · 2004
- Descendant · 3 generations on · 4 of its ownK050035 Elekta Neuromag with Maxwell FilterElekta Neuromag OY · 2005
- Descendant · 3 generations on · 2 of its ownK091393 Elekta Neuromag with MaxfilterElekta Neuromag OY · 2010
- Descendant · 4 generations on · 1 of its ownK233985 TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Megin OY · 2024
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K030737Omega Whole-Cortex MFG System, Models Omega 151, Omega 275Ctf Systems (2001), Inc. · 2003 · cites it directly10descendants
- K041264Elekta OYElekta Neuromag OY · 2004 · 2 generations on8descendants
- K050035Elekta Neuromag with Maxwell FilterElekta Neuromag OY · 2005 · 3 generations on4descendants
- K091393Elekta Neuromag with MaxfilterElekta Neuromag OY · 2010 · 3 generations on2descendants
- K233985TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Megin OY · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901215 | 700 Series Biomagnetometer | Biomagnetic Technologies, Inc. | 1990 | — |
| −1 | K962764 | Neuromag-122 | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| 0 (this device) | K971329 | CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem) | Ctf Systems, Inc. | 1997 | — |
| +1 | K030737 | Omega Whole-Cortex MFG System, Models Omega 151, Omega 275 | Ctf Systems (2001), Inc. | 2003 | — |
| +2 | K041264 | Elekta OY | Elekta Neuromag OY | 2004 | — |
| +3 | K050035 | Elekta Neuromag with Maxwell Filter | Elekta Neuromag OY | 2005 | — |
| +3 | K091393 | Elekta Neuromag with Maxfilter | Elekta Neuromag OY | 2010 | — |
| +4 | K233985 | TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) | Megin OY | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GWQ device
- #1 K260455 New Wave Systemscore 13.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962764 | Neuromag-122Summary page 2…entire surface of the brain simultaneously without having to move the position of the probe. 10—1 10.4. The CTF “Whole-Cortex MEG System” Neuromag-122 (K962764) and the Bioma (K901215A) in safety and effectiveness. Safety and Effectiveness is subslantially' equivalent to both the gneti… | 1996 |
| * | K901215 | 700 Series BiomagnetometerSummary page 2…ain simultaneously without having to move the position of the probe. 10—1 10.4. The CTF “Whole-Cortex MEG System” Neuromag-122 (K962764) and the Bioma (K901215A) in safety and effectiveness. Safety and Effectiveness is subslantially' equivalent to both the gnetic Technologies Magnes Si… | 1990 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K030737 (Ctf Systems (2001), Inc., 2003) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K962764.
How does its category compare?
All GWQ devicesGWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWQ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWQ
137in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWQ
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWQ
13in 2025
MAUDE reports naming product code GWQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 5 | 11 |
| 2008 | 2 | — | 2 | 8 |
| 2009 | 0 | — | 1 | 7 |
| 2010 | 3 | 73 | 1 | 12 |
| 2011 | 4 | 220 | 0 | 6 |
| 2012 | 4 | 208 | 0 | 9 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 7 |
| 2015 | 3 | 276 | 2 | 13 |
| 2016 | 3 | 50 | 0 | 28 |
| 2017 | 5 | 181 | 0 | 17 |
| 2018 | 8 | 150 | 0 | 15 |
| 2019 | 0 | — | 2 | 16 |
| 2020 | 6 | 216 | 1 | 30 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 3 | 216 | 0 | 16 |
| 2023 | 6 | 137 | 0 | 20 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (118 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971329 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971329: CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971329
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026