510(k) Report

Devices descending from K203103

5 later devices reach Synapse 3D, Synapse 3D Base Tools v6.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+2K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+2K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+3K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+3K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—