Zeta TMS Navigation System
FDA 510(k) clearance K261471 · decided 2026-07-09
Clearance details
- K-number
- K261471
- Device name
- Zeta TMS Navigation System
- Applicant
- Zeta Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2026-05-04
- Decision date
- 2026-07-09
- Days to decision
- 66 days
- Clearance type
- Special
- Product code
- QFF
- Device class
- 2
- Regulation number
- 882.5805
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TMS-Cobot TS MV (K182768) | Axilum Robotics | 2019-02-17 |
Recalls involving this device
No recalls on record reference this clearance.