510(k) Report

Devices descending from K031874

16 later devices reach Modification to WBR, Model HR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040370WBR-FHR, WBR-FWBUltraspect, Ltd.200415—
+2K103710WBR Xpress PetUltraspect, Ltd.20110—
+2K050815Xact.Cardiac & Xpress.CardiacUltraspect, Ltd.200514—
+3K081201WBR XPRESS3.CardiacUltraspect, Ltd.20082—
+3K080784WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.BoneUltraspect, Ltd.200813—
+4K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd.20119—
+4K091073WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering CorrectionsUltraspect, Ltd.20091—
+5K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd.20165—
+5K160120D-SPECT Processing and Reviewing WorkstationSpectrum Dynamics, Ltd.20162—
+6K212230TruSPECT Radiological Image Processing StationSpectrum Dynamics Medical, Ltd.20211—
+6K180514Veriton NMSpectrum Dynamics Medical, Ltd.20184—
+7K253532TruSPECT Processing StationSpectrum Dynamics Medical, Ltd.20250—
+7K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+8K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20192—
+9K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20231—
+10K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20260—