510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182768Substantially Equivalent

TMS-Cobot TS MV

Axilum Robotics, Strasbourg, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182768 is the FDA 510(k) clearance record for TMS-Cobot TS MV, a class II device, cleared for Axilum Robotics 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 one 510(k) clearance for Axilum Robotics. As of , FDA records show no recalls naming K182768.

Clearance record

Decision date
Received
(142 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
Axilum Robotics 8 Rue Schertz, Strasbourg, FR
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