Zeta Surgical today announced that its Zeta TMS Navigation System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The device is classified as a Class II stereotaxic instrument (21 CFR 882.4560) under product codes SGE and QFF (K251927).

The Zeta TMS Navigation System provides image‑guided, real‑time coil positioning for transcranial magnetic stimulation (TMS). The system combines 3D imaging and motion‑aware tracking to help maintain target alignment during patient movement. TMS is widely used in neuropsychiatry, particularly for treatment-resistant major depressive disorder (TR-MDD), which affects about one-third of patients with major depression worldwide.

The FDA clearance covers use of the Zeta TMS Navigation System as a stereotaxic image‑guidance system for accurate positioning of TMS treatment coils to planned brain targets using 3D patient imaging, for use by trained professionals in clinical environments—supporting deployment across a range of TMS procedures including therapeutic sessions and functional mapping.

“This clearance classifies the system under product codes QFF and SGE—and, to our knowledge, marks the first TMS navigation device cleared under SGE,” said Hieu Le Mau, Chief Operating Officer at Zeta Surgical. “It provides a clear regulatory pathway for broader adoption.”

Zeta Surgical recently completed a study in collaboration with the University of Cambridge and Harvard Medical School demonstrating sub‑millimeter translational and sub‑degree angular precision in bench, phantom, and cadaver testing for navigated TMS using its system.

“We expect this clearance to help clinics deliver more consistent targeting in TMS, which has been shown in research to significantly improve treatment efficacy,” said Jose Maria Amich, Co‑Founder and Chief Executive Officer of Zeta Surgical. “Our aim is to make stereotactic-grade, high‑accuracy image guidance practical in everyday neuromodulation workflows.”