Device product
Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities.
Z-1282-2016
Product summary
- Event
- Event 73606
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 angiography system
- Official record key
device-enforcement:Z-1282-2016
Official wording
Reason: After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Biosense Webster Inc.
Code information: Serial # 82010, material # 10848600
Distribution pattern: Nationwide Distribution to Michigan only
Derived failure modes
-
Unknown
After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Biosense Webster Inc.