FDA Product Code QFF: Electromechanical Arm For A Transcranial Magnetic Stimulation System
To Provide Guidance For The Positioning And Orientation Of A Transcranial Magnetic Stimulation (tms) System Coil Under The Supervision Of A Tracking System.
Leading manufacturers include Axilum Robotics.
2
Total
2
Cleared
104d
Avg days
2019
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times improving: avg
66d
recently vs 142d historically
FDA 510(k) Cleared Electromechanical Arm For A Transcranial Magnetic Stimulation System Devices (Product Code QFF)
2 devices
About Product Code QFF - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QFF since 2019, with 2 receiving FDA clearance (average review time: 104 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - QFF Product Code
Recent submissions under QFF have taken an average of 66 days to reach a decision - down from 142 days historically, suggesting improved FDA processing for this classification.
QFF devices are reviewed by the Neurology panel. Browse all Neurology devices →