Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation So…
FDA 510(k)Class II (US FDA 510(k))
by Brainlab AG
Identifiers
- 510(k) Number
- K192703 FDA 510(k)
- FDA Product Code
- HAW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cranial Image Guided Surgery System is a navigation system intended to enable navigated surgery when used with a compatible navigation platform and compatible instrument accessories. It includes Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), and Intraoperative Structure Update components.
The system is supplied by Brainlab AG and is authorized under FDA 510K clearance with product code HAW. It is designed for use in neurology and ENT procedures, with Automatic Registration technology enabling integration of intraoperative MRI and other imaging devices with image-guided surgery to optimize workflow while maintaining the preoperative surgical plan.
Frequently asked questions
What is the Brainlab Cranial Image Guided Surgery System used for?
The system is intended to enable navigated surgery when used with compatible navigation platforms and instrument accessories, specifically designed for neurology and ENT procedures.
What components are included in the Cranial Image Guided Surgery System?
The system includes Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), and Intraoperative Structure Update components.
How does the Automatic Registration 2.0 technology benefit surgical procedures?
Automatic Registration technology enables integration of intraoperative MRI and other imaging devices with image-guided surgery to optimize workflow while maintaining the preoperative surgical plan.
What is the regulatory status of this system?
The system is authorized under FDA 510K clearance with product code HAW, received on September 27, 2019, with a decision date of October 8, 2020.
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: Cranial Image Guided Surgery System, Navigation Software Cranial ..., Cranial Navigation: Advanced Neuronavigation | Brainlab, Curve: Image Guided Surgery - Go Beyond Navigation | Brainlab
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192703 | Class II | Active |
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Manufacturer
- Manufacturer
- Brainlab AG
Sources (1)
- FDA 510(k) K192703 24 fields · synced Sep 28, 2026