FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro
K Number: K232235
·
Decision Oct 25, 2023
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
65
Applicant Total
13
Review Days
90
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Basic Information
- Device Name
- Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro
- K Number
- K232235
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5805
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Magstim Company , Ltd.
- Date Received
- July 27, 2023
- Decision Date
- October 25, 2023
- Product Code
- OBP
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OBP | Transcranial Magnetic Stimulator | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OBP), ordered by most recent decision date.
MagVenture Accelerated TMS (aTMS) Therapy System
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·Neurology
Apollo TMS Therapy System;Apollo light TMS Therapy System
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Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
FDA 510(k)
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Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
FDA 510(k)
FDA Class 2
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SPRY TMS Therapy System (0550)
FDA 510(k)
FDA Class 2
·Neurology
BrainsWay Deep TMS System
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by The Magstim Company , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K130403 | MAGSTIM DOUBLE 70-2 COIL | Aug 23, 2013 | Substantially Equivalent |
| K083242 | NEUROSIGN AVALANCHE MOTOR NERVE MONITOR | Jul 29, 2009 | Substantially Equivalent |
| K080499 | MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 | Dec 8, 2008 | Substantially Equivalent |
| K071349 | NEUROSIGN LARYNGEAL ELECTRODES | Dec 12, 2007 | Substantially Equivalent |
| K051864 | MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00 | Dec 21, 2005 | Substantially Equivalent |
| K053141 | NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 | Dec 14, 2005 | Substantially Equivalent |
| K991583 | NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR | May 19, 1999 | Substantially Equivalent |
| K980148 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR | Aug 5, 1998 | Substantially Equivalent |
| K964869 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR | May 14, 1997 | Substantially Equivalent |
| K945799 | NEUROSIGN 100 IMPEDANCE METER | Jun 2, 1995 | Substantially Equivalent |