510(k) K261471
K261471 is an FDA 510(k) premarket notification submitted by Zeta Surgical, Inc. for the device "Zeta TMS Navigation System". The FDA issued a decision of Substantially Equivalent on July 9, 2026. The device falls under product code QFF (Electromechanical Arm For A Transcranial Magnetic Stimulation System), a Class II device regulated under 21 CFR 882.5805. Zeta Surgical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 2026
- Date Received
- May 4, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electromechanical Arm For A Transcranial Magnetic Stimulation System
- Device Class
- Class II
- Regulation Number
- 882.5805
- Review Panel
- NE
- Submission Type
To provide guidance for the positioning and orientation of a transcranial magnetic stimulation (TMS) system coil under the supervision of a tracking system.