Zeta TMS Navigation System
The Zeta TMS Navigation System is a stereotaxic, image-guided planning and guidance system enabling computer-assisted procedures. The system assists the trained clinical professionals with…
Extracranial Positional System for a Transcranial Magnetic Stimulation System
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Guangdong.
- Shenzhen Yingchi Technology Co., Ltd. Guangdong
What Is This Device?
Intended for spatial positioning and orientation of the treatment coil for transcutaneous magnetic stimulation systems under the supervision of a tracking system.
How Is SGE Classified?
Extracranial Positional System For A Transcranial Magnetic Stimulation System is FDA product code SGE, Class 2, 21 CFR 882.4560.
What Does It Take to Sell It in the United States?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
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