510(k) Report

Devices descending from K221677

4 later devices reach Synapse 3D Base Tools v6.6 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+1K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+2K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+2K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—