3 results
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45ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Intelerad InteleShare software, with ProViewer component
FDA Enforcement
Class II
·Ongoing·DICOM Grid, Inc.·December 24, 2025
Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.
FDA Enforcement
Class II
·Terminated·DICOM GRID INC·January 25, 2017
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
FDA Enforcement
Class II
·Ongoing·DICOM Grid, Inc. d/b/a Ambra Health·October 5, 2022