FDA-Device2016-03-30Class II

syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional procedures. .

Siemens Medical Solutions USA, Inc
Hazard

After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.

Sold states
Nationwide Distribution to IL, NY, MT, and MN.
Affected count
6
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional procedures. .

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1232-2016

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