FDA-Device2022-10-05Class II
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
DICOM Grid, Inc. d/b/a Ambra Health
Hazard
A race condition between the storage system and services database has the potential to revert edits made to patient information upon first ingestion of a study.
Sold states
Domestic: AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, DC, & PR.
Affected count
671 downloads
Manufactured in
450 Park Ave S Fl 10-111, N/A, New York, NY, United States
Products
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1818-2022Don't want to check this manually?
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