Identity
- Trade Name
- tracking tools FDA UDI
- Generic Name
- Stereotactic neuronavigation/planning system FDA UDI
- Device Name
- StimGuide component FDA UDI
- Model / Reference
- NT-150 FDA UDI
- Description
- StimGuide component FDA UDI
Identifiers
- Primary DI / UDI-DI
- B195NT150 FDA UDI
- 510(k) Number
- K183376 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Stereotactic neuronavigation/planning system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Stereotactic neuronavigation/planning system
tracking tools by eemagine Medical Imaging Solutions GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stereotactic neuronavigation/planning system.
- Localite TMS Navigator TS — LOCALITE GmbH · Class II
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- Nexstim NBS Orange Head Tracker — Nexstim Oyj · Class II
- Localite TMS Navigator TS — LOCALITE GmbH · Class II
- Localite TMS Navigator TS — LOCALITE GmbH · Class II
- Localite TMS Navigator TS — LOCALITE GmbH · Class II
- Localite TMS Navigator TS — LOCALITE GmbH · Class II
- Anterior Disc Prep — SeaSpine Orthopedics Corporation · Class I
Cleared under the same submission
K183376 also covers:
- HORIZON™ 230V US Mains Filter — The Magstim Company , Ltd.
- StimGuide BNC Ground Lead — The Magstim Company , Ltd.
- StimGuide RS232 Lead — The Magstim Company , Ltd.
- StimGuide Trigger Lead — The Magstim Company , Ltd.
- eego amplifier — eemagine Medical Imaging Solutions GmbH
- stimguide — eemagine Medical Imaging Solutions GmbH
- stimguide — eemagine Medical Imaging Solutions GmbH
- stimguide — eemagine Medical Imaging Solutions GmbH
- tracking tools — eemagine Medical Imaging Solutions GmbH
- tracking tools — eemagine Medical Imaging Solutions GmbH
- tracking tools — eemagine Medical Imaging Solutions GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- eemagine Medical Imaging Solutions GmbH
Sources (1)
- FDA UDI 293ed464-0a7b-4c87-8a43-e4244fc86d3b 35 fields · synced May 30, 2026