510(k) Report

Devices descending from K080784

13 later devices reach WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.Bone through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd.20119—
+1K103710WBR Xpress PetUltraspect, Ltd.20110—
+1K091073WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering CorrectionsUltraspect, Ltd.20091—
+1K081201WBR XPRESS3.CardiacUltraspect, Ltd.20082—
+2K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd.20165—
+2K160120D-SPECT Processing and Reviewing WorkstationSpectrum Dynamics, Ltd.20162—
+3K212230TruSPECT Radiological Image Processing StationSpectrum Dynamics Medical, Ltd.20211—
+3K180514Veriton NMSpectrum Dynamics Medical, Ltd.20184—
+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—