FDA-Device2024-03-13Class II
Synapse PACS - Version 7.1.000US
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
3 Units (3 US)
Manufactured in
81 Hartwell Ave Ste 300, Lexington, MA, United States
Products
Synapse PACS - Version 7.1.000US
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1269-2024Don't want to check this manually?
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