510(k) Report

Devices descending from K003264

25 later devices reach QPS/BPGS/Moco Processing Applications for Entegra Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd.20119—
+1K052430Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp.20057—
+1K023110Cedars-Sinai Motion Correction (Moco) Software, Model 111005Digirad Corp.20029—
+1K022428Quantitative Blood Pool Spect (QBS)Adac Laboratories20024—
+2K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd.20165—
+2K160120D-SPECT Processing and Reviewing WorkstationSpectrum Dynamics, Ltd.20162—
+2K082904Stasys Motion Correction SoftwareDigirad Corp.20080—
+2K082368Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect Imaging…Digirad Corp.20081—
+2K070542Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp.20076—
+2K040326Autoquant PlusAdac Laboratories20043—
+3K213731EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile WorkflowsEver Fortune.Ai, Co., Ltd.20220—
+3K212230TruSPECT Radiological Image Processing StationSpectrum Dynamics Medical, Ltd.20211—
+3K180514Veriton NMSpectrum Dynamics Medical, Ltd.20184—
+3K100838Ergo Imaging SystemDigirad Corp.20102—
+3K083649Cardius 3 X-ActDigirad Corp.20090—
+3K072191Clearvision Nuclear Medicine Imaging SystemGvi Technology Partners20070—
+3K060020Autoquant PlusAdac Laboratories20061—
+4K253532TruSPECT Processing StationSpectrum Dynamics Medical, Ltd.20250—
+4K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+4K123408Ergo Imaging SystemDigirad Corp.20130—
+4K110384Dilon 6800 Acella (Acella)Dilon Technologies, Inc.20110—
+4K100714CSMC Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01Cedars-Sinai Medical Center20110—
+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—