510(k) Report

Devices descending from K110507

9 later devices reach Cardiac Scanner and Processing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd.20165—
+1K160120D-SPECT Processing and Reviewing WorkstationSpectrum Dynamics, Ltd.20162—
+2K212230TruSPECT Radiological Image Processing StationSpectrum Dynamics Medical, Ltd.20211—
+2K180514Veriton NMSpectrum Dynamics Medical, Ltd.20184—
+3K253532TruSPECT Processing StationSpectrum Dynamics Medical, Ltd.20250—
+3K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+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—