510(k) Report

Devices descending from DEN040007

21 later devices reach Implantable Radio Frequency Transponder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170423DentureID MicrochipCmp Industries, LLC20170—
+1K071355Smartsponge SystemClearcount Medical Solutions, Inc.20074—
+1K062450D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd.200614—
+2K100551Orlocate System Model Orl 100Haldor Advanced Technologies, Ltd.20100—
+2K080124Ventri 1.1Ge Medical Systems F.I. Haifa200822
+2K073180Smartsponge Plus SystemClearcount Medical Solutions, Inc.20072—
+2K072468Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd.2007101
+3K212004MyoSPECT, MyoSpect ESGE Healthcare202101
+3K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd.20119—
+3K093557Smartwand-DTXClearcount Medical Solutions20091—
+3K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa200801
+4K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd.20165—
+4K160120D-SPECT Processing and Reviewing WorkstationSpectrum Dynamics, Ltd.20162—
+4K113021Trufreeze System, Trufreeze Spray KitCSA Medical, Inc.20120—
+5K212230TruSPECT Radiological Image Processing StationSpectrum Dynamics Medical, Ltd.20211—
+5K180514Veriton NMSpectrum Dynamics Medical, Ltd.20184—
+6K253532TruSPECT Processing StationSpectrum Dynamics Medical, Ltd.20250—
+6K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+7K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20192—
+8K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20231—
+9K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20260—