510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261471Substantially Equivalent

Zeta TMS Navigation System

Zeta Surgical Inc., Boston MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K261471 is the FDA 510(k) clearance record for Zeta TMS Navigation System, a class II device, cleared for Zeta Surgical, Inc. on under FDA product code QFF (Electromechanical Arm For A Transcranial Magnetic Stimulation System). FDA's definition for product code QFF reads: "To provide guidance for the positioning and orientation of a transcranial magnetic stimulation (TMS) system coil under the supervision of a tracking system". FDA records list 6 510(k) clearances for Zeta Surgical, Inc., from to . As of , FDA records show no recalls naming K261471.

Clearance record

Decision date
Received
(66 days to decision)
Product code
QFF Electromechanical Arm For A Transcranial Magnetic Stimulation System
Regulation
21 CFR 882.5805
Device class
Class II
Review panel
Neurology
Applicant
Zeta Surgical, Inc. 280 Summer St., Boston MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QFF

Trailing 12 months
1 clearance under product code QFF in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QFF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260