← Back to catalogue
Localite TMS Navigator TS
FDA 510(k)FDA UDIClass II (US FDA 510(k))
510(k) K223577
Identity
- Trade Name
- Localite TMS Navigator TS FDA UDI
- Generic Name
- Stereotactic neuronavigation/planning system FDA UDI
- Model / Reference
- Camera Cart for Vega (LAN Cabling) FDA UDI
Identifiers
- Catalog Number
- 900649 FDA UDI
- Primary DI / UDI-DI
- G076A900649A0 FDA UDI
- 510(k) Number
- FDA Product Code
- HAW FDA 510(k)FDA UDI
- GMDN Term
- Stereotactic neuronavigation/planning system FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)FDA UDI
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
No
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
Yes
FDA UDI
MR Unsafe FDA UDI
Localite TMS Navigator TS by LOCALITE GmbH — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223577 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LOCALITE GmbH
Sources (2)
- FDA 510(k) K223577 24 fields · synced Jun 18, 2026
- FDA UDI 1d528e3e-2b3f-4957-baad-218375a5b76a 34 fields · synced May 27, 2026