510(k) Report

Devices descending from K061029

26 later devices reach Jetstream Workspace through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152503ImagenSPECTCardiovascular Imaging Technologies20161—
+1K080961NM Application SuitePhilips Nuclear Medicine, Inc.2008121
+1K072468Modification to D-Spect Cardiac Scanner SystemSpectrum Dynamics, Ltd.2007101
+2K201933ImagenSPECT 3.0Cardiovascular Imaging Technologies20200—
+2K111731Molecular Breast Imaging SoftwareGamma Medica-Ideas Incorporated20110—
+2K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd.20119—
+2K111336EBW NM 2.0Philips Medical Systems (Cleveland), Inc.20119—
+2K111024Jetpack 2.0Philips Medical Systems (Cleveland), Inc.20110—
+3K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+3K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd.20165—
+3K160120D-SPECT Processing and Reviewing WorkstationSpectrum Dynamics, Ltd.20162—
+3K151212Ziostation2Qi Imaging, LLC20152—
+4K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+4K210831OnQ NeuroCortechs Labs, Inc.20213—
+4K212230TruSPECT Radiological Image Processing StationSpectrum Dynamics Medical, Ltd.20211—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K180514Veriton NMSpectrum Dynamics Medical, Ltd.20184—
+5K253532TruSPECT Processing StationSpectrum Dynamics Medical, Ltd.20250—
+5K250416GBrain MRIGalileo Cds, Inc.20251—
+5K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+6K252362GBrain MRIGalileo Cds, Inc.20250—
+6K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20192—
+7K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20231—
+8K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…Spectrum Dynamics Medical, Ltd.20260—