510(k) Report

Devices descending from K201597

4 later devices reach Liver Incytes, Model 1005 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223287VelacurSonic Incytes20233—
+2K232459VelacurSonic Incytes20232—
+3K233977VelacurSonic Incytes20241—
+4K251728Velacur One (LI-1100)Sonic Incytes Medical Corp20250—