Nexstim Inc.
Helsinki Uusimaa, FI
NEXSTIM INC. appears in FDA device records in Helsinki Uusimaa, FI. FDA records list 4 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Nexstim Inc. between 2009 and 2019. The busiest year on record is 2009, with 1. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2012 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K182700 | Nexstim Navigated Brain Therapy (NBT) System 2 | OBP | Substantially Equivalent | |
| K171902 | Nexstim Navigated Brain Therapy (NBT) System 2 | OBP | Substantially Equivalent | |
| K112881 | NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM) | GWF | Substantially Equivalent | |
| K091457 | NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM | GWF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009543145 | 3009543145 | NEXSTIM INC. | 2921 Landmark Place, Madison, WI 53713 US | 2026 | No device listings on this registration |
| 3007147067 | 3007147067 | NEXSTIM PLC | Elimaenkatu 9B, Helsinki Uusimaa 00510 FI | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2320-2017 | NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals. | Software defect: the NBS software may accidentally generate duplicate copies of one or several files. | Class II | Open, Classified | |
| Z-2319-2017 | Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals. | Software defect: the NBS software may accidentally generate duplicate copies of one or several files. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain