FDA-Device2024-03-13Class II
Synapse PACS - Version 7.2.100
FUJIFILM Healthcare Americas Corporation
Hazard
Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Sold states
Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, Namibia, Netherlands, Portugal, Qatar, Spain, Thailand, Turkey, UAE, United Kingdom.
Affected count
35 Units (28 US, 7 OUS)
Manufactured in
81 Hartwell Ave Ste 300, Lexington, MA, United States
Products
Synapse PACS - Version 7.2.100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1271-2024Don't want to check this manually?
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