510(k) Report

Devices descending from K133135

3 later devices reach Impax Volume Viewing 3.0 through their predicates, nearest generation first.

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