510(k) · Cleared
ClearedCN-Suite™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
FIND Surgical Sciences Inc. D/B/A FIND Neuro · OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Cleared on Aug 16, 2026 as substantially equivalent to K201910 (Neurologic, LLC, 2020) and 1 other predicate after a 178-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Aug 16, 2026
- Review
- 178 days
- Class
- Class II
- Product code
- OLX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K901215 (1990). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK901215 700 Series BiomagnetometerBiomagnetic Technologies, Inc. · 1990
- 7 generations backK962764 Neuromag-122Philips Medical Systems (Cleveland), Inc. · 1996
- 6 generations backK971329 CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem)Ctf Systems, Inc. · 1997
- 5 generations backK030737 Omega Whole-Cortex MFG System, Models Omega 151, Omega 275Ctf Systems (2001), Inc. · 2003
- 4 generations backK041264 Elekta OYElekta Neuromag OY · 2004
- 3 generations backK050035 Elekta Neuromag with Maxwell FilterElekta Neuromag OY · 2005
- 2 generations backK091393 Elekta Neuromag with MaxfilterElekta Neuromag OY · 2010
- 1 generation backK233985 TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Megin OY · 2024
- This deviceK260563 CN-Suite™FIND Surgical Sciences Inc. D/B/A FIND Neuro · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K901215 | 700 Series Biomagnetometer | Biomagnetic Technologies, Inc. | 1990 | — |
| −7 | K962764 | Neuromag-122 | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −6 | K971329 | CTF Systems Inc, Whole-Cortex Meg System (with Optional Eeg Subsystem) | Ctf Systems, Inc. | 1997 | — |
| −5 | K030737 | Omega Whole-Cortex MFG System, Models Omega 151, Omega 275 | Ctf Systems (2001), Inc. | 2003 | — |
| −4 | K041264 | Elekta OY | Elekta Neuromag OY | 2004 | — |
| −3 | K050035 | Elekta Neuromag with Maxwell Filter | Elekta Neuromag OY | 2005 | — |
| −2 | K091393 | Elekta Neuromag with Maxfilter | Elekta Neuromag OY | 2010 | — |
| −1 | K233985 | TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) | Megin OY | 2024 | — |
| 0 (this device) | K260563 | CN-Suite™ | FIND Surgical Sciences Inc. D/B/A FIND Neuro | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 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 K233985 TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)score 12.1 · 7 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 |
|---|---|---|---|
| * | K201910 | EZTrackSummary page 6…= Page 6 === 1.3 Legally Marketed Predicate/Reference Devices 1.3.1 EZTrack The primary predicate device for the CN-Suite™ is the EZTrack cleared under K201910. 510(k) Number K201910 Trade Name: EZTrack Regulation Name: Electroencephalogra… | 2020 |
| * | K233985 | TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Summary page 6…netoencephalograph 510(k) Review Panel: Neurology 1.3.2 MEGreview An additional predicate device for the CN-Suite™ is the MEGreview cleared under K233985. 510(k) Number K233985 Trade Name: TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) Regul… | 2024 |
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 36 years and passes through 7 companies; a new generation was cleared every 5.7 years on median.
- None of the 10 ancestors has a recall.
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. 2026, 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?
The CN-Suite™ is intended for use by trained and qualified clinicians (e.g., EEG technologists, epileptologists, and neurosurgeons) on adult and pediatric patients (aged 3 years and older) with focal or multifocal epilepsy for the visualization and quantitative analysis of brain network dynamics derived from intracranial electrophysiological recordings (iEEG). CN-Suite™ calculates and displays patient-specific Criticality Values for each analysis node.…
Read the full statement (169 words)
The CN-Suite™ is intended for use by trained and qualified clinicians (e.g., EEG technologists, epileptologists, and neurosurgeons) on adult and pediatric patients (aged 3 years and older) with focal or multifocal epilepsy for the visualization and quantitative analysis of brain network dynamics derived from intracranial electrophysiological recordings (iEEG).
CN-Suite™ calculates and displays patient-specific Criticality Values for each analysis node. Criticality Values are continuous quantitative metrics derived from delay-adjusted, non-linear directed causality analysis of spatiotemporal electrophysiological patterns and are intended to assist trained clinicians in identifying and prioritizing brain regions that may be relevant during presurgical evaluation. Device outputs are intended to be interpreted in conjunction with the original electrophysiological recordings, neuroimaging data, and other available clinical information.
CN-Suite™ provides quantitative clinical decision-support information and does not provide autonomous diagnostic conclusions or treatment recommendations. The software does not independently determine the epileptogenic zone or recommend surgical intervention. Device outputs are intended to support, but not replace, multidisciplinary clinical judgment and should always be interpreted together with other available clinical information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260563 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260563: CN-Suite™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260563
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026