510(k) · Cleared
Clearedvisor2 system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eemagine Medical Imaging Solutions GmbH · HAW Neurological Stereotaxic Instrument
Cleared on Apr 8, 2022 as substantially equivalent to K191422 (Soterix Medical, Inc., 2020) after a 444-day review. Its family tree reaches back 7 generations to 2008. 1 later device descends from it.
- Decided
- Apr 8, 2022
- Review
- 444 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to DEN070003 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 6 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 5 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 4 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 3 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 2 generations backK171902 Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc · 2017
- 1 generation backK191422 Neural NavigatorSoterix Medical, Inc. · 2020
- This deviceK210109 visor2 systemEemagine Medical Imaging Solutions GmbH · 2022
- Descendant · cites it directly · 0 of its ownK261228 QuickVision Ultimate rTMSBrain Ultimate, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261228QuickVision Ultimate rTMSBrain Ultimate, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −6 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −5 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −4 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −3 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −2 | K171902 | Nexstim Navigated Brain Therapy (NBT) System 2 | Nexstim Plc | 2017 | — |
| −1 | K191422 | Neural Navigator | Soterix Medical, Inc. | 2020 | — |
| 0 (this device) | K210109 | visor2 system | Eemagine Medical Imaging Solutions GmbH | 2022 | — |
| +1 | K261228 | QuickVision Ultimate rTMS | Brain Ultimate, 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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K191422 | Neural NavigatorSummary page 4…eemagine.com Classification Name: Repetitive Transcranial Magnetic Stimulation System 21 CFR 882.4560, Product Code: HAW, Class II Primary Predicate: K191422, Neural Navigator CEO/Geschäftsführer: Manufacturer: Soterix… | 2020 |
| † | K183376 | HORIZON TMS Therapy System with Navigation | 2019 |
| † | K112881 | Nexstim Navigated Brain Stimulation (NBS) System 4, Nexstim NBS System 4 with Nexspeech… | 2012 |
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 |
|---|---|---|---|
| K261228 | QuickVision Ultimate rTMS | 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 14 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K261228 (Brain Ultimate, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K191422.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
visor2 is used to aid 3D navigation for positioning of Transcranial Magnetic Stimulation (TMS) coils over preselected brain regions based on data from MRI measurements or scalp landmarks and optional EMG recording in clinical procedures. The visor2 system is compatible with the following commercially available TMS coils of the following TMS companies: • Mag & More: PMD70-aCool Double coil Figure-8 (510575) • MagStim Company Ltd.: Double 70mm Remote Coil…
Read the full statement (123 words)
visor2 is used to aid 3D navigation for positioning of Transcranial Magnetic Stimulation (TMS) coils over preselected brain regions based on data from MRI measurements or scalp landmarks and optional EMG recording in clinical procedures. The visor2 system is compatible with the following commercially available TMS coils of the following TMS companies:
• Mag & More: PMD70-aCool Double coil Figure-8 (510575)
• MagStim Company Ltd.: Double 70mm Remote Coil (3190-00 rev2), Double 70mm Air Film Coil (3910 00);
• MagVenture A/S: Double 75mm (C-B60), Double Cooled 75mm (Cool-B65), Double 95mm (D-B80), Angulated Double Cooled 97mm (Cool-B70 rev2), Butterfly figure-8 (C-B70)
• Neuronetics Inc.: NeuroStar coil
The visor2 system must be operated by a trained physician and must not be used during surgical operations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210109: visor2 system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210109
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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