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"Neobi" magnetic navigation system - Taiwan Registration 809633497196297becc495b10af05174

Access comprehensive regulatory information for "Neobi" magnetic navigation system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 809633497196297becc495b10af05174 and manufactured by STEREOTAXIS, INC.. The authorized representative in Taiwan is UPWARDS BIOSYSTEMS LTD..

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809633497196297becc495b10af05174
Registration Details
Taiwan FDA Registration: 809633497196297becc495b10af05174
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Device Details

"Neobi" magnetic navigation system
TW: โ€œ่€ๆญๆฏ”โ€็ฃๅฐŽ่ˆช็ณป็ตฑ
Risk Class 2
Cancelled

Registration Details

809633497196297becc495b10af05174

DHA00601897600

Company Information

United States

Product Details

The Niobe MNS Magnetic Navigation System and its software (Navigant) can control the orientation of the tip of the catheter with a magnetic force band using the external magnetic field change. This device provides the physician with direct control of the magnetic catheter end to reach a preset target position under the direct vision of the digital cardiac catheterization imaging system. The Niobe MNS is integrated with a digital X-ray system to obtain images of medical catheters and anatomical images of patients during interventional procedures. The Niobe MNS Magnetic Navigation System and its software (Navigant) control the tip orientation of the magnetic catheter to guide the magnetic catheter from the tissue into the patient's left or right heart and coronary vascular system to a pre-set position to facilitate interventional procedures. In short, the Niobe MNS generates a specific magnetic field that is used to orient the distant tip of a magneto-compatible device in the patient's body (heart). The end result is that the distal tip of the device can change to any direction as the physician adjusts the direction of the magnetic field. When this direction changes to the direction desired by the physician, the physician can deliver the device in that direction until a new direction needs to be changed, and then adjust the direction of the magnetic field.

E Cardiovascular Medicine Science

E.1290 Controllable Guided Control System

import

Dates and Status

Mar 19, 2008

Mar 19, 2013

Apr 23, 2015

Cancellation Information

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