510(k) Report

Devices descending from K953801

25 later devices reach Varicam through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022960GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa200223Class I
+1K963162QuantemElscint, Inc.19960—
+2K102231Discovery NM 750BGe Medical Systems Israel, Functional Imaging20103—
+2K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa200913Class I
+2K051855VentriGe Medical Systems F.I. Haifa200533
+2K043381Infinia LightspeedGe Medical Systems F.I. Haifa20041—
+3K243605AuroraGe Medical Systems Israel, Functional Imaging20251—
+3K173816NM/CT 850, NM/CT 860GE Healthcare20180Class I
+3K160933Discovery NM 750b BopsyGE Healthcare20160—
+3K153402Discovery NM/CT 670 CZTGE Healthcare20166Class I
+3K111791Lumagem Molecular Breast Imaging SystemGamma Medica-Ideas Incorporated20111—
+3K111445Discovery NM 630GE Healthcare20112Class I
+3K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa200801
+3K080124Ventri 1.1Ge Medical Systems F.I. Haifa200822
+4K251153AuroraGe Medical Systems Israel20250—
+4K212004MyoSPECT, MyoSpect ESGE Healthcare202101
+4K210173StarGuideGE Healthcare20211—
+4K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+4K123408Ergo Imaging SystemDigirad Corp.20130—
+4K121019Optima NM/CT 640GE Healthcare20120Class I
+4K113350Brivo NM 615GE Healthcare20110Class I
+5K241350Clarify DLGe Medical Systems Israel, Functional Imaging20250—
+5K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20192—
+6K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20231—
+7K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20260—