QFF
- Product code
- QFF
- Device name
- Electromechanical Arm For A Transcranial Magnetic Stimulation System
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5805
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
FDA classification definition
To provide guidance for the positioning and orientation of a transcranial magnetic stimulation (TMS) system coil under the supervision of a tracking system.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K261471 | 2026-07-09 | Zeta Surgical, Inc. | Zeta TMS Navigation System summary |
Official FDA classification page: QFF
Classification and pathway per current FDA publications. Data from openFDA (CC0).