510(k) Report

Devices descending from K111945

2 later devices reach Impax Next Generation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+2K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—