510(k) · Cleared
ClearedNeuromag-122
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · OLY Magnetoencephalograph
Cleared on Oct 31, 1996 as substantially equivalent to K901215 (Biomagnetic Technologies, Inc., 1990) after a 107-day review. Its family tree reaches back 1 generation to 1990. 20 later devices descend from it.
- Decided
- Oct 31, 1996
- Review
- 107 days
- Class
- Class II
- Product code
- OLY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K901215 (1990). 20 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK901215 700 Series BiomagnetometerBiomagnetic Technologies, Inc. · 1990
- This deviceK962764 Neuromag-122Philips Medical Systems (Cleveland), Inc. · 1996
- Descendant · cites it directly · 12 of its ownK971329 CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem)Ctf Systems, Inc. · 1997
- Descendant · 2 generations on · 10 of its ownK030737 Omega Whole-Cortex MFG System, Models Omega 151, Omega 275Ctf Systems (2001), Inc. · 2003
- Descendant · 3 generations on · 8 of its ownK041264 Elekta OYElekta Neuromag OY · 2004
- Descendant · cites it directly · 5 of its ownK033488 Cmi MagnetocardiographCmi Cardiomag Imaging, Inc. · 2004
- Descendant · 4 generations on · 4 of its ownK050035 Elekta Neuromag with Maxwell FilterElekta Neuromag OY · 2005
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K971329CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem)Ctf Systems, Inc. · 1997 · cites it directly12descendants
- K030737Omega Whole-Cortex MFG System, Models Omega 151, Omega 275Ctf Systems (2001), Inc. · 2003 · 2 generations on10descendants
- K041264Elekta OYElekta Neuromag OY · 2004 · 3 generations on8descendants
- K033488Cmi MagnetocardiographCmi Cardiomag Imaging, Inc. · 2004 · cites it directly5descendants
- K050035Elekta Neuromag with Maxwell FilterElekta Neuromag OY · 2005 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901215 | 700 Series Biomagnetometer | Biomagnetic Technologies, Inc. | 1990 | — |
| 0 (this device) | 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 | — |
| +2 | K030737 | Omega Whole-Cortex MFG System, Models Omega 151, Omega 275 | Ctf Systems (2001), Inc. | 2003 | — |
| +3 | K041264 | Elekta OY | Elekta Neuromag OY | 2004 | — |
| +1 | K033488 | Cmi Magnetocardiograph | Cmi Cardiomag Imaging, Inc. | 2004 | — |
| +4 | K050035 | Elekta Neuromag with Maxwell Filter | Elekta Neuromag OY | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 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 OLY? 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 OLY device
- #1 K191785 Orion LifeSpan MEGscore 0.0 · 5 generations · no Class I recall
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 |
|---|---|---|---|
| * | K901215 | 700 Series BiomagnetometerSummary page 2…thout having to move the position of the probe. 4, Safety and Effectiveness The Neuromag-122 is substantially equivalent to the Biomagnetic Technologies Magnes Single (K901215A) in safety and effectiveness. The following chart has been compiled to demonstrate Neuromag-122's substantial equivalence to thi… | 1990 |
What descends from it? (20)
See all 204 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?
How does its category compare?
All OLY devicesOLY Magnetoencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OLY
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · OLY
Too few OLY 510(k)s in any year since 2007 to give a median.
Recalls per year · OLY
No recall names OLY since 2007.
Adverse event reports per year · OLY
1in 2012
MAUDE reports naming product code OLY, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Neuromag-122 system is intended for use as a magneto encephalographic (MEG) device which non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. When interpreted by a trained clinician, the data enhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions.
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/K962764 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962764: Neuromag-122.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962764
Report an extraction error
Are you the manufacturer?
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