Zeta TMS Navigation System— 510(k) K261471
Substantially EquivalentZeta Surgical, Inc.
FDA 510(k) clearance K261471 for Zeta TMS Navigation System, Substantially Equivalent on 2026-07-09. Applicant: Zeta Surgical, Inc.. Device class: 2.
Summary
Zeta Surgical's Zeta TMS Navigation System is filed under QFF, electromechanical arms for a transcranial magnetic stimulation system. The record doesn't list the system's components.
Class II, 21 CFR 882.5805. Neurology is both the classification panel and the review panel, and it came in as a Special 510(k).
Zeta Surgical filed from Boston, Massachusetts. Review took 66 calendar days (May 4 to July 9, 2026).
Clearance details
- Applicant
- Zeta Surgical, Inc.
- Product code
- Product code QFF
- Device class
- Class 2
- Regulation
- 21 CFR 882.5805
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Boston, MA, US
Recent devices under product code QFF
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