510(k) Report

510(k) · Cleared

Cleared

Mag Vita TMS Therapy System w/Theta Burst Stimulation

K173620510(k) TraditionalCleared Aug 14, 2018265-day reviewClass II21 CFR 882.5805

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tonica Elektronik A/S · OBP Transcranial Magnetic Stimulator

Cleared on Aug 14, 2018 as substantially equivalent to K150641 (Tonica Elektronik A/S, 2015) and 3 other predicates after a 265-day review. Its family tree reaches back 7 generations to 2008. 39 later devices descend from it.

Decided
Aug 14, 2018
Review
265 days
Class
Class II
Product code
OBP
Recalls
None
Predicates
4

Its longest line of descent runs back 7 generations to DEN070003 (2008). 12 ancestors in all. 39 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2017: 3 other ancestors2015: 1 other ancestor2016: 1 other ancestor2019: 3 descendants cleared2025: 12 descendants cleared2020: 1 descendant cleared2021: 2 descendants cleared2022: 2 descendants cleared2024: 4 descendants cleared2023: 8 descendants cleared2026: 7 descendants cleared×2: 2 generations cleared close together, DEN070003 (2008), K083538 (2008) K130233 · Neurostar TMS Therapy System · Neuronetics · 2013K133408 · Neurostar TMS Therapy System · Neuronetics · 2014K143531 · Rapid Therapy System · Magstim Company Limited · 2015 · recalledK160309 · Neurosoft TMS · Teleemg, LLC · 2016K171967 · MagVita TMS Therapy System · Tonica Elektronik A/S · 201720052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors 1 generation forward: 9 descendants2 generations forward: 10 descendants3 generations forward: 11 descendants4 generations forward: 3 descendants5 generations forward: 4 descendants6 generations forward: 2 descendants K171967 · MagVita TMS Therapy System · Tonica Elektronik A/S · 2017K160309 · Neurosoft TMS · Teleemg, LLC · 2016K143531 · Rapid Therapy System · Magstim Company Limited · 2015 · recalledK133408 · Neurostar TMS Therapy System · Neuronetics · 2014K130233 · Neurostar TMS Therapy System · Neuronetics · 2013K083538 · Neurostar TMS Therapy System, Model 1.1 · Neuronetics · 2008 · recalledDEN070003 · Neurostar TMS System · Neuronetics · 2008−50+5
  1. Root · 7 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
  2. 6 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
  3. 5 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
  4. 4 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
  5. 3 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
  6. 2 generations backK160309 Neurosoft TMSTeleemg, LLC · 2016
  7. 1 generation backK171967 MagVita TMS Therapy SystemTonica Elektronik A/S · 2017
  8. This deviceK173620 Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018
  9. Descendant · cites it directly · 24 of its ownK193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS…Tonica Elektronik A/S · 2020
  10. Descendant · 2 generations on · 19 of its ownK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…Neuronetics, Inc. · 2022
  11. Descendant · 3 generations on · 13 of its ownK230029 NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
  12. Descendant · cites it directly · 10 of its ownK182853 HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2019 · Recalled
  13. Descendant · 4 generations on · 7 of its ownK231926 NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 2024 · Recalled

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2019: 32020: 12021: 22022: 22023: 82024: 42025: 122026: 7
2019high 12 (2025) · low 1 (2020)2026

Most influential descendants

Showing 5 of 39 · See all
  • K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemTonica Elektronik A/S · 2020 · cites it directly24descendants
  • K212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy…Neuronetics, Inc. · 2022 · 2 generations on19descendants
  • K230029NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023 · 3 generations on13descendants
  • K182853HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2019 · cites it directly10descendants
  • K231926NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 2024 · 4 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7DEN070003Neurostar TMS SystemNeuronetics2008—
−6K083538Neurostar TMS Therapy System, Model 1.1Neuronetics20081
−5K130233Neurostar TMS Therapy SystemNeuronetics2013—
−4K133408Neurostar TMS Therapy SystemNeuronetics2014—
−3K143531Rapid Therapy SystemMagstim Company Limited20153
−2K160309Neurosoft TMSTeleemg, LLC2016—
−1K171967MagVita TMS Therapy SystemTonica Elektronik A/S2017—
0 (this device)K173620Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S2018—
+1K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemTonica Elektronik A/S2020—
+2K212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced…Neuronetics, Inc.2022—
+3K230029NeuroStar Advanced Therapy System (Version 3.7)Neuronetics2023—
+1K182853HORIZON TMS Therapy SystemMagstim Company, Ltd.20192
+4K231926NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc.20241

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201730

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201930
202010
202120
202220
202380
202440
2025120
202670
FIG. 1 — Lineage of K173620, 2008–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 OBP? 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 OBP device

  1. #1 K251119 MagVenture TMS Therapy Systemscore 21.8 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K150641MagVita TMS Therapy System
Summary page 4
…r [21 CFR 882.5805, Product Code OBP] Classification: Class II Medical Device Predicate Devices: MagVita TMS Therapy System (K150641, K171481, K171967 and K172667) 21 CFR 882.5805, Repetitive Transcranial Magne…
Tonica Elektronik A/S2015—
*K171481MagVita TMS Therapy System
Summary page 4
…882.5805, Product Code OBP] Classification: Class II Medical Device Predicate Devices: MagVita TMS Therapy System (K150641, K171481, K171967 and K172667) 21 CFR 882.5805, Repetitive Transcranial Magnetic…
Tonica Elektronik A/S2017—
*K171967MagVita TMS Therapy System
Summary page 4
…OBP] Classification: Class II Medical Device Predicate Devices: MagVita TMS Therapy System (K150641, K171481, K171967 and K172667) 21 CFR 882.5805, Repetitive Transcranial Magnetic Stimulation…
Tonica Elektronik A/S2017—
*K172667MagVita TMS Therapy w/MagPro R20
Summary page 4
…OBP] Classification: Class II Medical Device Predicate Devices: MagVita TMS Therapy System (K150641, K171481, K171967 and K172667) 21 CFR 882.5805, Repetitive Transcranial Magnetic Stimulation…
Tonica Elektronik A/S2017—

Also cleared against K150641: 10 other devices →

What descends from it? (39)

See all 39

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemTonica Elektronik A/S202024
K182853HORIZON TMS Therapy SystemMagstim Company, Ltd.201910
K183376HORIZON TMS Therapy System with NavigationMagstim Company, Ltd.20197
K182700Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc20193
K251125MagVenture TMS Therapy SystemTonica Elektronik A/S20251
K243460Ultimate rTMSBrain Ultimate, Inc.20251
K243319Ampa One System (AMPA-001)Neuromodulatory Devices & Applications20251
K250689CloudTMS EdgeTeleemg, LLC20250
K203735Brainsway Deep TMS SystemBrainsway, Ltd.20210

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 10 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
  • 2 of the 12 ancestors have a recall of any class.
  • Of its descendants, K193006 (Tonica Elektronik A/S, 2020) has gone furthest, with 24 descendants of its own.
  • 10 other devices also cite its predicate K150641.

How does its category compare?

All OBP devices

OBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · OBP

12in 2025

2008: 22013: 22014: 12015: 22016: 32017: 82018: 42019: 32020: 12021: 52022: 62023: 72024: 52025: 122026 (partial year): 8
2007high 12 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OBP

125in 2025

2016: 101 days median2017: 73 days median2018: 144 days median2019: 156 days median2021: 132 days median2022: 168 days median2023: 119 days median2024: 266 days median2025: 125 days median2026 (partial year): 176 days median
2007high 266 (2024) · low 73 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OBP

1in 2018

2009: 12018: 12026 (partial year): 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OBP

81in 2025

2009: 32011: 52012: 32013: 12015: 32016: 62017: 32018: 62019: 122020: 122021: 152022: 592023: 432024: 502025: 81
2007high 81 (2025) · low 0 (2007)2025

MAUDE reports naming product code OBP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20082—00
20090—13
20100—00
20110—05
20120—03
20132—01
20141—00
20152—03
2016310106
201787303
2018414416
20193156012
20201—012
20215132015
20226168059
20237119043
20245266050
202512125081
202681761—

What is it indicated for?

The MagVita TMS Therapy System w/ Theta Burst Stimulation is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

Indications for use as stated in the FDA summary.

Also cleared against K150641

10 other devices cite the same predicate.

  • K251125MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025
  • K252032T65 (9016E061-)Tonica Elektronik A/S · 2025
  • K232688NQ TMS for MDD (NQv1-MU-01)Neuroqore, Inc. · 2023
  • K212723BTL-995-rTMSBTL Industries, Inc. · 2022
  • K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemTonica Elektronik A/S · 2020
  • K182768TMS-Cobot TS MVAxilum Robotics · 2019

More from Tonica Elektronik A/S

18 FDA decisions under this applicant name. See the company

  • K260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/S · 2026
  • K251125MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025
  • K251119MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025
  • K252032T65 (9016E061-)Tonica Elektronik A/S · 2025
  • K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOptionTonica Elektronik A/S · 2023

Recent decisions in OBP

The OBP category page

  • K260396KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)Fidelity BioPharma Co. · 2026
  • K260691BTL-699BTL Industries, Inc. · 2026
  • K261228QuickVision Ultimate rTMSBrain Ultimate, Inc. · 2026
  • K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbH · 2026
  • K260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/S · 2026

https://510kreport.com/device/K173620 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173620: Mag Vita TMS Therapy System w/Theta Burst Stimulation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173620

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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