510(k) · Cleared
ClearedOrion LifeSpan MEG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compumedics Limited · OLY Magnetoencephalograph
Cleared on Feb 14, 2020 as substantially equivalent to K041264 (Elekta Neuromag OY, 2004) after a 226-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Feb 14, 2020
- Review
- 226 days
- Class
- Class II
- Product code
- OLY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K901215 (1990). No later device cites it as a predicate yet.
- 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 deviceK191785 Orion LifeSpan MEGCompumedics Limited · 2020
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) | K191785 | Orion LifeSpan MEG | Compumedics Limited | 2020 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 4…numbers: 21 CFR 882.1400 Predicate Device Information: Trade Name: Elekta Neuromag Manufacturer: Elekta Neuromag Oy 510(k) number: K041264 Product code: OLY, GWQ, OLX Device class: II Regulation numbers: 21 CFR 882.1400… | 2004 |
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 30 years and passes through 6 companies; a new generation was cleared every 5.9 years on median.
- None of the 5 ancestors has a recall.
- 5 other devices also cite its predicate K041264.
How does its category compare?
All OLY devicesOLY Magnetoencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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 Orion LifeSpan MEG non-invasively measures the magnetoencephalographic (MEG) (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…
Read the full statement (190 words)
The Orion LifeSpan MEG non-invasively measures the magnetoencephalographic (MEG) (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, and somatosensory 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 the device may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning.
It is assumed that the users of the Orion LifeSpan™ MEG are physicians or neurology laboratory technicians who have received training in the following areas:
• Hospital procedures
• Physiological monitoring of patients
• Training relevant to the specific discipline or disorder under investigation
Note: This indication for use specifically excludes use of the Orion LifeSpan™ MEG as life support equipment, for example vital signs monitoring in intensive care units.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191785: Orion LifeSpan MEG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191785
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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