510(k) Report

Devices descending from K111638

4 later devices reach Impax Volume Viewing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133135Impax Volume Viewing 3.0Agfa Healthcare N.V.20143—
+2K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+2K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+2K142316IMPAX AgilityAgfa Healthcare N.V.20151—