12 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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Change Healthcare Cardiology Hemodynamics Software
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·July 9, 2025
Change Healthcare Cardiology Hemo Software
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·July 9, 2025
Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 23, 2024
Horizon Cardiology Hemo. Version 12.2.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 23, 2024
McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 23, 2024
McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·April 15, 2020
Change Healthcare Radiology Solutions 14.0
FDA Enforcement
Class II
·Terminated·CHANGE HEALTHCARE CANADA COMPANY·October 14, 2020
Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·June 9, 2021
Change Healthcare Enterprise Viewer
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·May 5, 2021
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·December 20, 2023
Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·November 15, 2023
Change Healthcare Radiology Solutions software version 14.2.2
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 8, 2025