510(k) Report

Devices descending from K914807

3 later devices reach Apex Helix - a through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080124Ventri 1.1Ge Medical Systems F.I. Haifa200822
+2K212004MyoSPECT, MyoSpect ESGE Healthcare202101
+2K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa200801