11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
FDA Enforcement
Class II
·Terminated·Mckesson Medical Immaging·August 6, 2014
Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
FDA Enforcement
Class II
·Terminated·Mckesson Medical Immaging·June 18, 2014
McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
FDA Enforcement
Class II
·Terminated·Mckesson Medical Immaging·May 21, 2014
McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.
FDA Enforcement
Class II
·Terminated·Mckesson Medical Immaging·March 23, 2016
McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
FDA Enforcement
Class II
·Terminated·Mckesson Medical Imaging Group·September 28, 2016
McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
FDA Enforcement
Class II
·Terminated·Mckesson Information Solutions LLC·October 29, 2014
McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data.
FDA Enforcement
Class II
·Terminated·McKesson Israel Ltd.·September 12, 2018
McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
FDA Enforcement
Class II
·Terminated·Mckesson Information Solutions LLC·October 15, 2014
McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems.
FDA Enforcement
Class II
·Terminated·Mckesson Information Solutions LLC·October 9, 2013
McKesson Radiology 12.2 - Picture Archive Communication System (PACS)
FDA Enforcement
Class II
·Terminated·Mckesson Medical Imaging·March 8, 2017
Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).
FDA Enforcement
Class II
·Terminated·Mckesson Medical Imaging Group·August 29, 2012