510(k) Report

Devices descending from K980715

15 later devices reach Autoquant Quantitative Perfusion Spect (QPS) & Quantitative Gated Spect (QGS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd.20119—
+1K072468Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd.2007101
+1K040326Autoquant PlusAdac Laboratories20043—
+2K213731EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile WorkflowsEver Fortune.Ai, Co., Ltd.20220—
+2K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd.20165—
+2K160120D-SPECT Processing and Reviewing WorkstationSpectrum Dynamics, Ltd.20162—
+2K060020Autoquant PlusAdac Laboratories20061—
+3K212230TruSPECT Radiological Image Processing StationSpectrum Dynamics Medical, Ltd.20211—
+3K180514Veriton NMSpectrum Dynamics Medical, Ltd.20184—
+3K100714CSMC Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01Cedars-Sinai Medical Center20110—
+4K253532TruSPECT Processing StationSpectrum Dynamics Medical, Ltd.20250—
+4K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+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—