Company: Agfa Healthcare NV Date of Enforcement Report 10/17/2018 Class II: PRODUCT Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as PACS Recall Number: Z-0101-2019 REASON Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the...Read More

FDA released a final guidance "Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications 510(k) with Different Technological Characteristics" dated Sept. 25, 2018.  This guidance applies only to devices with similar intended use and if the different technological characteristics do not raise different questions of Safety and Effectiveness.  Read the full guidance at...Read More