510(k) · Cleared
ClearedOmega Whole-Cortex MFG System, Models Omega 151, Omega 275
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ctf Systems (2001), Inc. · OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Cleared on Oct 10, 2003 as substantially equivalent to K971329 (Ctf Systems, Inc., 1997) after a 214-day review. Its family tree reaches back 3 generations to 1990. 10 later devices descend from it.
- Decided
- Oct 10, 2003
- Review
- 214 days
- Class
- Class II
- Product code
- OLX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K901215 (1990). 10 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK901215 700 Series BiomagnetometerBiomagnetic Technologies, Inc. · 1990
- 2 generations backK962764 Neuromag-122Philips Medical Systems (Cleveland), Inc. · 1996
- 1 generation backK971329 CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem)Ctf Systems, Inc. · 1997
- This deviceK030737 Omega Whole-Cortex MFG System, Models Omega 151, Omega 275Ctf Systems (2001), Inc. · 2003
- Descendant · cites it directly · 8 of its ownK041264 Elekta OYElekta Neuromag OY · 2004
- Descendant · 2 generations on · 4 of its ownK050035 Elekta Neuromag with Maxwell FilterElekta Neuromag OY · 2005
- Descendant · 2 generations on · 2 of its ownK091393 Elekta Neuromag with MaxfilterElekta Neuromag OY · 2010
- Descendant · 3 generations on · 1 of its ownK233985 TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Megin OY · 2024
- Descendant · 4 generations on · 0 of its ownK260563 CN-Suite™FIND Surgical Sciences Inc. D/B/A FIND Neuro · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K041264Elekta OYElekta Neuromag OY · 2004 · cites it directly8descendants
- K050035Elekta Neuromag with Maxwell FilterElekta Neuromag OY · 2005 · 2 generations on4descendants
- K091393Elekta Neuromag with MaxfilterElekta Neuromag OY · 2010 · 2 generations on2descendants
- K233985TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Megin OY · 2024 · 3 generations on1descendant
- K260563CN-Suite™FIND Surgical Sciences Inc. D/B/A FIND Neuro · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K901215 | 700 Series Biomagnetometer | Biomagnetic Technologies, Inc. | 1990 | — |
| −2 | K962764 | Neuromag-122 | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −1 | K971329 | CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem) | Ctf Systems, Inc. | 1997 | — |
| 0 (this device) | K030737 | Omega Whole-Cortex MFG System, Models Omega 151, Omega 275 | Ctf Systems (2001), Inc. | 2003 | — |
| +1 | K041264 | Elekta OY | Elekta Neuromag OY | 2004 | — |
| +2 | K050035 | Elekta Neuromag with Maxwell Filter | Elekta Neuromag OY | 2005 | — |
| +2 | K091393 | Elekta Neuromag with Maxfilter | Elekta Neuromag OY | 2010 | — |
| +3 | K233985 | TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) | Megin OY | 2024 | — |
| +4 | K260563 | CN-Suite™ | FIND Surgical Sciences Inc. D/B/A FIND Neuro | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 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 OLX? 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 OLX device
- #1 K260563 CN-Suite™score 13.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K971329 | CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem)Summary page 1…y Committee: Neurology Establishment Registration Number (Owner/Operator): 9034609 Predicate Device Information CTF Systems Inc. Whole-Cortex MEG System as cleared by K971329 Device Description The Omega Whole-Cortex MEG Systems integrate up to 307 dc-SQUID axial gradiometers with workstation computer… | 1997 |
What descends from it? (10)
2 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 13 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K041264 (Elekta Neuromag OY, 2004) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K971329.
How does its category compare?
All OLX devicesOLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OLX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLX
462in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLX
No recall names OLX since 2007.
Adverse event reports per year · OLX
1in 2015
MAUDE reports naming product code OLX, 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 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 462 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.…
Read the full statement (120 words)
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.
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/K030737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030737: Omega Whole-Cortex MFG System, Models Omega 151, Omega 275.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030737
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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