510(k) · Cleared
ClearedZeta TMS Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeta Surgical, Inc. · QFF Electromechanical Arm For A Transcranial Magnetic Stimulation System
Cleared on Jul 9, 2026 as substantially equivalent to K251927 (Zeta Surgical, Inc., 2025) and 1 other predicate after a 66-day review. Its family tree reaches back 9 generations to 2008.
- Decided
- Jul 9, 2026
- Review
- 66 days
- Class
- Class II
- Product code
- QFF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to DEN070003 (2008). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 5 generations between
- 3 generations backK191422 Neural NavigatorSoterix Medical, Inc. · 2020
- 2 generations backK223577 Localite TMS Navigator TSLocalite GmbH · 2023
- 1 generation backK251927 Zeta Navigation System (ZNS131-US)Zeta Surgical, Inc. · 2025
- This deviceK261471 Zeta TMS Navigation SystemZeta Surgical, Inc. · 2026
Show all 9 generations
- Root · 9 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 8 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 7 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 6 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 5 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 4 generations backK171902 Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc · 2017
- 3 generations backK191422 Neural NavigatorSoterix Medical, Inc. · 2020
- 2 generations backK223577 Localite TMS Navigator TSLocalite GmbH · 2023
- 1 generation backK251927 Zeta Navigation System (ZNS131-US)Zeta Surgical, Inc. · 2025
- This deviceK261471 Zeta TMS Navigation SystemZeta Surgical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −8 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −7 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −6 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −5 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −4 | K171902 | Nexstim Navigated Brain Therapy (NBT) System 2 | Nexstim Plc | 2017 | — |
| −3 | K191422 | Neural Navigator | Soterix Medical, Inc. | 2020 | — |
| −2 | K223577 | Localite TMS Navigator TS | Localite GmbH | 2023 | — |
| −1 | K251927 | Zeta Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2025 | — |
| 0 (this device) | K261471 | Zeta TMS Navigation System | Zeta Surgical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 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 QFF? 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? (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 |
|---|---|---|---|
| * | K251927 | Zeta Navigation System (ZNS131-US)Summary page 5…21 CFR 882.4560 Regulatory Class: Class II Product Code: QFF, SGE 3. PREDICATE DEVICE Zeta TMS Navigation System [K251927] TMS-Cobot TS MV, AXILUM Robotics [K182768] 4. DEVICE DESCRIPTION The Zeta TMS Navigation System… | 2025 |
| * | K182768 | TMS-Cobot TS MVSummary page 5…lass II Product Code: QFF, SGE 3. PREDICATE DEVICE Zeta TMS Navigation System [K251927] TMS-Cobot TS MV, AXILUM Robotics [K182768] 4. DEVICE DESCRIPTION The Zeta TMS Navigation System is a stereotaxic, image-guided planning and guidance… | 2019 |
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 18 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 11 ancestors have a recall of any class.
How does its category compare?
All QFF devicesQFF Electromechanical Arm For A Transcranial Magnetic Stimulation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QFF
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · QFF
Too few QFF 510(k)s in any year since 2007 to give a median.
Recalls per year · QFF
No recall names QFF since 2007.
Adverse event reports per year · QFF
No MAUDE report names QFF 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 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 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…
Read the full statement (109 words)
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. In addition, the product is intended for use with the Apollo TMS Therapy System supplied by MAG & More GmbH (Munich, Germany), only with the following magnetic coils: PMD70-aCool.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261471 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261471: Zeta TMS Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261471
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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