FDA-Device2019-11-27Class II
Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intraoperative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. Fiducial Arrays are plastic parts that contain metal beads, which serve as the fiducia
Neocis Inc.
Hazard
The Fiducial Array may mismatch their measurement files resulting in failed landmark check.
Sold states
US Nationwide distribution in the states of AR, OK, NY.
Affected count
3 units
Manufactured in
2800 Biscayne Blvd Ste 600, N/A, Miami, FL, United States
Products
Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intraoperative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. Fiducial Arrays are plastic parts that contain metal beads, which serve as the fiducial CBCT markers.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0511-2020Don't want to check this manually?
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