Stereotaxis Niobe Magnetic Navigation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K021555 FDA 510(k)
- FDA Product Code
- DXX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1290 FDA 510(k)
- Regulation Number
- 870.1290 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Stereotaxis Niobe Magnetic Navigation System is a steerable catheter control system used for cardiovascular procedures. It is classified as a Class II medical device and was found substantially equivalent through the FDA 510(k) clearance process.
The system requires a 3-phase 480/400 Volt AC 40 amp electrical panel for operation. It is manufactured by Stereotaxis, Inc. and is authorized under FDA 510(k) clearance K021555.
Frequently asked questions
What is the Stereotaxis Niobe Magnetic Navigation System used for?
The Stereotaxis Niobe Magnetic Navigation System is a steerable catheter control system used for cardiovascular procedures, enabling precise navigation of catheters during interventions through magnetic field manipulation.
What electrical requirements does the Stereotaxis Niobe system have for operation?
The system requires a 3-phase 480/400 Volt AC 40 amp electrical panel to operate, as specified in its technical specifications for proper function in a clinical environment.
Is the Stereotaxis Niobe Magnetic Navigation System a reusable or single-use device?
The Stereotaxis Niobe Magnetic Navigation System is a reusable capital equipment system designed for multiple procedures; it is not a single-use device, as it consists of a permanent console and reusable components requiring maintenance and calibration between uses.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Stereotaxis Products, Stereotaxis (company) - Wikipedia, PDF PRO-1022 Niobe Magnetic Navigation System with Stereotaxis Imaging
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K021555 | Class II | Active |
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Manufacturer
- Manufacturer
- Stereotaxis, Inc.
Sources (1)
- FDA 510(k) K021555 24 fields · synced Sep 27, 2026