| Device |
extracranial positional system for a transcranial magnetic stimulation system |
| Regulation Description |
Stereotaxic instrument. |
| Definition |
Intended for spatial positioning and orientation of the treatment coil for transcutaneous magnetic stimulation systems under the supervision of a tracking system. |
| Physical State |
A mechanical or electromechanical arm with or without a cart, a tracking system, software, 3D camera, coil adoption kit with or without its mechanical adaptor and a contact sensor. |
| Technical Method |
A tracking system measures the position and orientation of the patient’s head and the software uses the measurements provided by the tracking system to move the robotic arm and position the coil. A contact sensor allows the software to measure amount of contact applied by the coil onto the head to prevent unexpected collisions. |
| Target Area |
Head |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | SGE |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Physical Medicine Devices
(DHT5B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.4560
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
