52 results
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36ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
FDA Enforcement
Class II
·Terminated·Canon Inc.·June 5, 2013
Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
FDA Enforcement
Class II
·Terminated·Canon Inc.·September 5, 2012
Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.
FDA Enforcement
Class II
·Terminated·Neuro Kinetics, Inc.·September 9, 2015
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