2 results
·
40ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.
FDA Recall
Terminated
·DICOM GRID INC·Product code LLZ·December 16, 2016
Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+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