510(k) · Cleared
ClearedElekta Neuromag with Maxwell Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Neuromag OY · OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Cleared on Jan 25, 2005 as substantially equivalent to K041264 (Elekta Neuromag OY, 2004) after an 18-day review. Its family tree reaches back 5 generations to 1990. 4 later devices descend from it.
- Decided
- Jan 25, 2005
- Review
- 18 days
- Class
- Class II
- Product code
- OLX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K901215 (1990). 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK901215 700 Series BiomagnetometerBiomagnetic Technologies, Inc. · 1990
- 4 generations backK962764 Neuromag-122Philips Medical Systems (Cleveland), Inc. · 1996
- 3 generations backK971329 CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem)Ctf Systems, Inc. · 1997
- 2 generations backK030737 Omega Whole-Cortex MFG System, Models Omega 151, Omega 275Ctf Systems (2001), Inc. · 2003
- 1 generation backK041264 Elekta OYElekta Neuromag OY · 2004
- This deviceK050035 Elekta Neuromag with Maxwell FilterElekta Neuromag OY · 2005
- Descendant · cites it directly · 2 of its ownK091393 Elekta Neuromag with MaxfilterElekta Neuromag OY · 2010
- Descendant · 2 generations on · 1 of its ownK233985 TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Megin OY · 2024
- Descendant · 3 generations on · 0 of its ownK260563 CN-Suite™FIND Surgical Sciences Inc. D/B/A FIND Neuro · 2026
- Descendant · cites it directly · 0 of its ownK081430 Elekta Neuromag with Maxwell Filter with Internal Active ShieldingElekta Neuromag OY · 2008
Most influential descendants
Showing 4 of 4 · See all- K091393Elekta Neuromag with MaxfilterElekta Neuromag OY · 2010 · cites it directly2descendants
- K233985TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Megin OY · 2024 · 2 generations on1descendant
- K260563CN-Suite™FIND Surgical Sciences Inc. D/B/A FIND Neuro · 2026 · 3 generations on0descendants
- K081430Elekta Neuromag with Maxwell Filter with Internal Active ShieldingElekta Neuromag OY · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901215 | 700 Series Biomagnetometer | Biomagnetic Technologies, Inc. | 1990 | — |
| −4 | K962764 | Neuromag-122 | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −3 | K971329 | CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem) | Ctf Systems, Inc. | 1997 | — |
| −2 | K030737 | Omega Whole-Cortex MFG System, Models Omega 151, Omega 275 | Ctf Systems (2001), Inc. | 2003 | — |
| −1 | K041264 | Elekta OY | Elekta Neuromag OY | 2004 | — |
| 0 (this device) | K050035 | Elekta Neuromag with Maxwell Filter | Elekta Neuromag OY | 2005 | — |
| +1 | K091393 | Elekta Neuromag with Maxfilter | Elekta Neuromag OY | 2010 | — |
| +2 | K233985 | TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) | Megin OY | 2024 | — |
| +3 | K260563 | CN-Suite™ | FIND Surgical Sciences Inc. D/B/A FIND Neuro | 2026 | — |
| +1 | K081430 | Elekta Neuromag with Maxwell Filter with Internal Active Shielding | Elekta Neuromag OY | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2024 | 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 14.0 · 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 |
|---|---|---|---|
| * | K041264 | Elekta OYSummary page 1…510(k) # Elekta Neuromag® K041264 5. Other relevant submissions… | 2004 |
What descends from it? (4)
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 15 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K091393 (Elekta Neuromag OY, 2010) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K041264.
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 Elekta Neuromag® with Maxwell Filter 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…
Read the full statement (121 words)
The Elekta Neuromag® with Maxwell Filter 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 as stated in the FDA summary.
https://510kreport.com/device/K050035 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050035: Elekta Neuromag with Maxwell Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050035
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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