Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Some pacs and workstations vendors implement a distance measurement calculation that is ihe compliant for magnified images. when sending magnified images acquired by ge senographe 2000d mammography systems to these workstations distance measurement may be inaccurate and the caregiver may underestimate a breast lesion/tumor. this issue does not exist for images done with contact mode. a combination of pixel spacing dicom tags and estimated radiographic magnification dicom tag influence the measurement result of the magnified images on the diagnostic review workstation. in the mammography industry the pixel spacing information has been coded in different ways since the introduction of digital images. the ihe initiative established a clear recommendation however it has not been implemented by all systems. as the first company to create digital mammography images ge has implemented a specific codification of the calibration of pixel size information that is not consistent with the more recent ihe recommendation. ge senographe 2000d full field digital mammography system ( seno 2000d) systems implement this ge coding schema. some non-ge review workstations may not be able to interpret this type of coding properly. therefore distance measurements on ge magnified images that are pushed to certain non-ge review workstations could cause lesion size measurement errors on magnified views. additionally true size display or true size printing of magnified views on dicom printers can also be affected. all ge multisystem review workstations (seno advantage 2.X and idi) are now able to identify and correctly interpret both ge coding and ihe coding. ge seno advantage 1.X review workstation can only read ge coding.