Cube 4D Navigation System, VirtuEye Pro
Device Facts
| Record ID | K261540 |
|---|---|
| Device Name | Cube 4D Navigation System, VirtuEye Pro |
| Applicant | Fiagon GmbH |
| Product Code | PGW · Neurology |
| Decision Date | Jun 2, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
