49 results
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75ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Alphenix INFX-8000H, interventional fluoroscopic x-ray system
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·February 4, 2026
Alphenix INFX-8000C, interventional fluoroscopic x-ray system
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·February 4, 2026
Alphenix INFX-8000V, interventional fluoroscopic x-ray system
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·February 4, 2026
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·February 4, 2026
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·January 21, 2026
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·January 21, 2026
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·October 15, 2025
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·November 13, 2024
Vantage Titan, Model: MRT-1504
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·March 13, 2024
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020)
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·June 19, 2024
MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·March 13, 2024
MRI system: Vantage Elan, Model: MRT-2020
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·March 13, 2024
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·September 7, 2022
System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·July 6, 2022
Canon Aquilion One Vision, Model TSX-301C
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·April 22, 2020
Canon Aquilion Prime SP, Model TSX-303B
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·April 22, 2020
System INFX-8000V
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·March 17, 2021
Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is PC based devise that allows for worklist management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit, is configurable with up to two x-ray tubes, and has an auto switching function. This system is intended for use in conjunction with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck and limbs. The system is used for image acquisition, image display and transmission/output or images to external devices.
FDA Enforcement
Class II
·Terminated·Canon Medical System, USA, INC.·July 17, 2019
System INFX-8000F
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·March 17, 2021
Canon Aquilion Precision, Model TSX-304A
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·April 22, 2020