Stealth AXiS Cranial Clinical Application
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- Stealth AXiS Clinical Application EUDAMED
- Model / Reference
- 9736551 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00199150006427 EUDAMED
- Basic UDI-DI
- 0763000B00033808A EUDAMED
- 510(k) Number
- K253379 FDA 510(k)
- FDA Product Code
- HAW FDA 510(k)
- EMDN Code
- Z12011401 SURGICAL NAVIGATION SYSTEM EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Stealth AXiS Cranial Clinical Application is a neuronavigation system designed for precise intraoperative guidance during cranial surgeries. It integrates advanced imaging and real-time tracking to assist surgeons in aligning surgical instruments with pre-operative planning data, enhancing accuracy and reducing procedural risks.
This application is supplied as part of the StealthStation S7 surgical navigation system and is intended for use in sterile operating room environments. It is a reusable device, compatible with MRI-safe settings as defined by the manufacturer’s specifications, and requires appropriate calibration and maintenance. Authorized under FDA 510(k) clearance (K253379) and MDR compliance, it adheres to regulatory standards for medical imaging and surgical navigation devices.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K253379 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Navigation, Inc.
Sources (2)
- FDA 510(k) K253379 24 fields · synced Sep 18, 2026
- EUDAMED 3393b236-c11b-4103-baeb-543f22eab548 61 fields · synced Jul 9, 2026