3 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the ARTIS family 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 i.e., patient extremities. This does not include projection radiography. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code OWB·May 15, 2025
MAGEC 1 System
FDA Recall
Open, Classified
·NuVasive Specialized Orthopedics, Inc.·Product code PGN·June 25, 2019
Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840
FDA Recall
Open, Classified
·Western/Scott Fetzer Company·Product code ECX·October 16, 2021