510(k) · Cleared
ClearedElekta Neuromag with Maxwell Filter with Internal Active Shielding
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 Jul 28, 2008 as substantially equivalent to K041264 (Elekta Neuromag OY, 2004) and 1 other predicate after a 68-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Jul 28, 2008
- Review
- 68 days
- Class
- Class II
- Product code
- OLX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K901215 (1990). No later device cites it as a predicate yet.
- Root · 6 generations backK901215 700 Series BiomagnetometerBiomagnetic Technologies, Inc. · 1990
- 5 generations backK962764 Neuromag-122Philips Medical Systems (Cleveland), Inc. · 1996
- 4 generations backK971329 CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem)Ctf Systems, Inc. · 1997
- 3 generations backK030737 Omega Whole-Cortex MFG System, Models Omega 151, Omega 275Ctf Systems (2001), Inc. · 2003
- 2 generations backK041264 Elekta OYElekta Neuromag OY · 2004
- 1 generation backK050035 Elekta Neuromag with Maxwell FilterElekta Neuromag OY · 2005
- This deviceK081430 Elekta Neuromag with Maxwell Filter with Internal Active ShieldingElekta Neuromag OY · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K901215 | 700 Series Biomagnetometer | Biomagnetic Technologies, Inc. | 1990 | — |
| −5 | K962764 | Neuromag-122 | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −4 | K971329 | CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem) | Ctf Systems, Inc. | 1997 | — |
| −3 | K030737 | Omega Whole-Cortex MFG System, Models Omega 151, Omega 275 | Ctf Systems (2001), Inc. | 2003 | — |
| −2 | K041264 | Elekta OY | Elekta Neuromag OY | 2004 | — |
| −1 | K050035 | Elekta Neuromag with Maxwell Filter | Elekta Neuromag OY | 2005 | — |
| 0 (this device) | K081430 | Elekta Neuromag with Maxwell Filter with Internal Active Shielding | Elekta Neuromag OY | 2008 | — |
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? (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 |
|---|---|---|---|
| * | K041264 | Elekta OYSummary page 1…alograph, product code GWQ, Regulation: 882.1400 Class of device: ClassI1. ) y | a_l.{ The legally marketed device to which we are claiming equivalence (807.92(a)(3)} : K041264, Elekta Neuromag™, manufactured by Elekta Neuromag Oy and K050035, Elekta Neuromag® with Maxwell Filter. Description of device:… | 2004 |
| * | K050035 | Elekta Neuromag with Maxwell FilterSummary page 1…ClassI1. ) y | a_l.{ The legally marketed device to which we are claiming equivalence (807.92(a)(3)} : K041264, Elekta Neuromag™, manufactured by Elekta Neuromag Oy and K050035, Elekta Neuromag® with Maxwell Filter. Description of device: This premarket notification represents modifications made to our c… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- None of the 6 ancestors has a recall.
- 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. 2008, this device’s year, is highlighted.
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?
Elekta Neuromag® with active shielding non-invasively measures the magnetoencephalographic (MEGQ) 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 (120 words)
Elekta Neuromag® with active shielding non-invasively measures the magnetoencephalographic (MEGQ) 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 dcvices. 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 ncurosurgical 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/K081430 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081430: Elekta Neuromag with Maxwell Filter with Internal Active Shielding.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081430
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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