Device product
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.
Z-0511-2020
Product summary
- Firm
- Neocis Inc.
- Event
- Event 84070
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0511-2020
Official wording
Reason: The Fiducial Array may mismatch their measurement files resulting in failed landmark check.
Code information: Serial Numbers: FA-0128-02, FA-0129-02, FA0130-02
Distribution pattern: US Nationwide distribution in the states of AR, OK, NY.
Derived failure modes
-
Unknown
The Fiducial Array may mismatch their measurement files resulting in failed landmark check.