K251927 is an FDA 510(k) clearance for the Zeta Navigation System (ZNS131-US). This device is classified as a Extracranial Positional System For A Transcranial Magnetic Stimulation System (Class II - Special Controls, product code SGE).
Submitted by Zeta Surgical, Inc. (Boston, US). The FDA issued a Cleared decision on October 10, 2025, 109 days after receiving the submission on June 23, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560. Intended For Spatial Positioning And Orientation Of The Treatment Coil For Transcutaneous Magnetic Stimulation Systems Under The Supervision Of A Tracking System..
| 510(k) Number | K251927 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2025 |
| Decision Date | October 10, 2025 |
| Days to Decision | 109 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | SGE - Extracranial Positional System For A Transcranial Magnetic Stimulation System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
| Definition | Intended For Spatial Positioning And Orientation Of The Treatment Coil For Transcutaneous Magnetic Stimulation Systems Under The Supervision Of A Tracking System. |