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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K210900
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INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE 2 08/11/2023 Canon Medical System, USA, INC.
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used i... 2 02/16/2024 Canon Medical System, USA, INC.
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional ang... 2 10/08/2025 Canon Medical System, USA, INC.
Alphenix INFX-8000C, interventional fluoroscopic x-ray system 2 01/27/2026 Canon Medical System, USA, INC.
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