510(k) · Cleared
ClearedMegvision, Model EQ1000C Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eagle Technology, Inc. · OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Cleared on Mar 24, 2004 as substantially equivalent to K971329 (Ctf Systems, Inc., 1997) and 1 other predicate after a 72-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it.
- Decided
- Mar 24, 2004
- Review
- 72 days
- Class
- Class II
- Product code
- OLX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K901215 (1990). 1 later device descends from it, 1 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 deviceK040051 Megvision, Model EQ1000C SeriesEagle Technology, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK210199 Ricoh MegRicoh Company, Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K210199Ricoh MegRicoh Company, Ltd. · 2021 · cites it directly0descendants
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) | K040051 | Megvision, Model EQ1000C Series | Eagle Technology, Inc. | 2004 | — |
| +1 | K210199 | Ricoh Meg | Ricoh Company, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (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 |
|---|---|---|---|
| * | K971329 | CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem)Summary page 1…ujihira 1/5/2004 MEGvision EQ1000C Serics Magnetoencepholographic (MEG) Device Electroencephalograph 21CFR882.1400 OLX, QLY Predicate Device(s) 510(k) # Manufacturer K971329 CTF Systems, Inc. K962764 Neuromag Ltd. MEGvision (EQ1000C Series) Eagle Technology, Inc. Ky ees .2/'3 3 poeges… | 1997 |
| * | K962764 | Neuromag-122Summary page 1…on EQ1000C Serics Magnetoencepholographic (MEG) Device Electroencephalograph 21CFR882.1400 OLX, QLY Predicate Device(s) 510(k) # Manufacturer K971329 CTF Systems, Inc. K962764 Neuromag Ltd. MEGvision (EQ1000C Series) Eagle Technology, Inc. Ky ees .2/'3 3 poeges Begpe Technalogy , Inc. 8… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210199 | Ricoh Meg | 2021 | 0 |
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 14 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K210199 (Ricoh Company, Ltd., 2021) has gone furthest, with 0 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 MEGvision is intended for use as a magnetoencephalographic (MEG) device which non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. When interpreted by a trained technician, 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/K040051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040051: Megvision, Model EQ1000C Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040051
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