510(k) · Cleared
ClearedZeta Navigation System (ZNS131-US)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeta Surgical, Inc. · SGE Extracranial Positional System For A Transcranial Magnetic Stimulation System
Cleared on Oct 10, 2025 as substantially equivalent to K223577 (Localite GmbH, 2023) after a 109-day review. Its family tree reaches back 8 generations to 2008. 1 later device descends from it.
- Decided
- Oct 10, 2025
- Review
- 109 days
- Class
- Class II
- Product code
- SGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to DEN070003 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 7 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 6 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 5 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 4 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 3 generations backK171902 Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc · 2017
- 2 generations backK191422 Neural NavigatorSoterix Medical, Inc. · 2020
- 1 generation backK223577 Localite TMS Navigator TSLocalite GmbH · 2023
- This deviceK251927 Zeta Navigation System (ZNS131-US)Zeta Surgical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK261471 Zeta TMS Navigation SystemZeta Surgical, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261471Zeta TMS Navigation SystemZeta Surgical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −7 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −6 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −5 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −4 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −3 | K171902 | Nexstim Navigated Brain Therapy (NBT) System 2 | Nexstim Plc | 2017 | — |
| −2 | K191422 | Neural Navigator | Soterix Medical, Inc. | 2020 | — |
| −1 | K223577 | Localite TMS Navigator TS | Localite GmbH | 2023 | — |
| 0 (this device) | K251927 | Zeta Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2025 | — |
| +1 | K261471 | Zeta TMS Navigation System | Zeta Surgical, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 SGE? 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 |
|---|---|---|---|
| * | K223577 | Localite TMS Navigator TSSummary page 5…Stereotaxic instrument, 21 CFR 882.4560 Regulatory Class: Class II Product Code: SGE, QFF 3. PREDICATE DEVICE Localite TMS Navigator TS [K223577] 4. DEVICE DESCRIPTION The Zeta TMS Navigation System is a stereotaxic, image guided planning and intraoperative guidance s… | 2023 |
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 |
|---|---|---|---|
| K261471 | Zeta TMS Navigation System | 2026 | 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 17 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K261471 (Zeta Surgical, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All SGE devicesSGE Extracranial Positional System For A Transcranial Magnetic Stimulation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SGE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SGE
Too few SGE 510(k)s in any year since 2007 to give a median.
Recalls per year · SGE
No recall names SGE since 2007.
Adverse event reports per year · SGE
No MAUDE report names SGE since 2007.
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 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Zeta TMS Navigation System is a stereotaxic image guidance system intended for accurate positioning of the treatment coil of TMS systems with respect to target brain locations based on data obtained from 3D patient imaging.
The product is intended for use with the MagVenture therapy systems supplied by Tonica Elektronik A/S (Farum, Denmark), more precisely the R30 stimulator, the R30 stimulator with MagOption, the X100 stimulator and the X100 stimulator with MagOption only with following magnetic coils: Cool-B65 RO.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251927: Zeta Navigation System (ZNS131-US).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251927
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