Vectorvision Spine
FDA 510(k)Class II (US FDA 510(k))
by Brainlab AG
Identifiers
- 510(k) Number
- K053159 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 Vectorvision Spine is a neurological stereotaxic instrument designed as an intraoperative image-guided localization system for minimally invasive surgery. It functions by linking a freehand probe, tracked by a passive marker sensor system, to virtual computer image space on a patient's preoperative image data processed by a Vectorvision workstation.
This system is supplied for use in clinical settings as a Class II device under FDA 510(k) clearance. It is identified by the product code HAW and is subject to special controls as a neurological stereotaxic instrument.
Frequently asked questions
What is the primary function of the Vectorvision Spine?
The Vectorvision Spine is an intraoperative image-guided localization system. It functions by linking a freehand probe, tracked by a passive marker sensor system, to virtual computer image space on a patient's preoperative image data processed by a Vectorvision workstation.
What is the regulatory classification of this device?
The Vectorvision Spine is classified as a Class II neurological stereotaxic instrument under FDA 510(k) clearance. It is identified by product code HAW and is subject to specific special controls for this device category.
In what clinical environment is this system intended to be used?
This system is intended for use in clinical settings specifically for minimally invasive surgery. It provides surgeons with image-guided localization to assist in navigating anatomical structures during procedures.
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: PDF 510 (k)Summary of Safety and Effectiveness for VectorVision spine, BRAINLAB VECTORVISION SYSTEM USER'S MANUAL Pdf Download, K053159 FDA 510 (k) - VECTORVISION SPINE | Brainlab AG
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K053159 | Class II | Active |
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Manufacturer
- Manufacturer
- Brainlab AG
Sources (1)
- FDA 510(k) K053159 24 fields · synced Sep 21, 2026