510(k) Report

Devices descending from K080124

2 later devices reach Ventri 1.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212004MyoSPECT, MyoSpect ESGE Healthcare202101
+1K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa200801