Taiwan FDA registration 809633497196297becc495b10af05174

"Neobi" magnetic navigation system

TW: “耐歐比”磁導航系統

Taiwan·Risk Class 2·STEREOTAXIS, INC.·Registered Mar 19, 2008 – Mar 19, 2013Cancelled

Registration details

Analysis ID: 809633497196297becc495b10af05174
Customs Code: DHA00601897600

Company information

Manufacturer: STEREOTAXIS, INC.
Manufacturer Country: United States
Authorized Representative: UPWARDS BIOSYSTEMS LTD.

Product details

Intended Use: 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.
Product Type (Level 1): E Cardiovascular Medicine Science
Product Type (Level 2): E.1290 Controllable Guided Control System
Import Information: import

Dates and status

Registration Date: Mar 19, 2008
Expiry Date: Mar 19, 2013
Cancellation Date: Apr 23, 2015

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

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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