510(k) Report

Devices descending from K052434

16 later devices reach Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121019Optima NM/CT 640GE Healthcare20120Class I
+1K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa200913Class I
+1K080927Brightview VCT Imaging SystemPhilips Medical Systems (Cleveland), Inc.20081Class I
+2K243605AuroraGe Medical Systems Israel, Functional Imaging20251—
+2K173816NM/CT 850, NM/CT 860GE Healthcare20180Class I
+2K153402Discovery NM/CT 670 CZTGE Healthcare20166Class I
+2K111445Discovery NM 630GE Healthcare20112Class I
+2K083649Cardius 3 X-ActDigirad Corp.20090—
+3K251153AuroraGe Medical Systems Israel20250—
+3K210173StarGuideGE Healthcare20211—
+3K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+3K113350Brivo NM 615GE Healthcare20110Class I
+4K241350Clarify DLGe Medical Systems Israel, Functional Imaging20250—
+4K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20192—
+5K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20231—
+6K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20260—