Product code SGE
- Device name
- Extracranial Positional System For A Transcranial Magnetic Stimulation System
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4560
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Intended for spatial positioning and orientation of the treatment coil for transcutaneous magnetic stimulation systems under the supervision of a tracking system.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K251927 | Zeta Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2025-10-10 |