510(k) Report

Devices descending from K954646

18 later devices reach Epi-II System Option W/High Performance Gradients through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K974530Duffusion-Weighted MR Imaging PackagePhilips Medical Systems (Cleveland), Inc.19981—
+1K964626Edge/Vista System Enhancement PackagePhilips Medical Systems (Cleveland), Inc.1997154
+2K050132Neuro II-SInnovative Magnetic Resonance Imaging Systems, Inc.20050—
+2K992412Ipass Bolus TrackingPhilips Medical Systems (Cleveland), Inc.19990—
+2K980831Image Post-Processing TechniquesPhilips Medical Systems (Cleveland), Inc.19980—
+2K974844Outlook System Enhancement PackagePhilips Medical Systems (Cleveland), Inc.199811—
+2K971884Asset ApolloPhilips Medical Systems (Cleveland), Inc.199701
+3K024042Panorama EnhancementsPhilips Medical Systems, Inc.20034—
+3K013858Infinion 0.6T MR Imaging SystemPhilips Medical Systems (Cleveland), Inc.200252
+3K983342MR Guided Procedures (MRGP) Basic PackagePhilips Medical Systems (Cleveland), Inc.19984—
+4K071154Superstar 0.35T Mri SystemNeusoft Medical Systems Co., Ltd.20073—
+4K022007Liberty 5000 Breast Coil with Disposable Biopsy PlatesUsa Instruments, Inc.20022—
+4K991943MRGP Optical Tracking UnitPhilips Medical Systems (Cleveland), Inc.19990—
+5K131737Supernova C5 Mri SystemLiaoning Kampo Medical System Co., Ltd.20140—
+5K092237NSM-S15 SystemNeusoft Medical Systems Co., Ltd.20090—
+5K082485Modification to Superopen 0.23T Mri System, Model Nam-P023ANeusoft Medical Systems Co., Ltd.20080—
+5K050728Open Breast Coil (Obc) with Biopsy PlatesUsa Instruments, Inc.20050—
+5K033353Modification to Liberty 5000 Breast Coil with Disposable Biopsy PlatesUsa Instruments, Inc.20030—