SGE
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Extracranial Positional System For A Transcranial Magnetic Stimulation System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Medical specialty
- Neurology
- FDA definition
- Intended for spatial positioning and orientation of the treatment coil for transcutaneous magnetic stimulation systems under the supervision of a tracking system.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Zeta Navigation System (ZNS131-US) (K251927) | Zeta Surgical, Inc. | 2025-10-10 |
Track SGE automatically
Every clearance here is in the API, with alerts when new ones post.