510(k) Report

Devices descending from K003437

42 later devices reach Odyssey LX, Model 211320 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230393UniCam Evo SoftwareInter Medical Medizintechnik GmbH20230—
+1K101279CORRIDOR4DM V2010 Model: V2010Invia201012—
+1K013673HI-Art SystemTomo Therapy, Inc.200227—
+2K2608794DMInvia, LLC20260—
+2K173512MFI-CardiacMultifunctional Imaging, LLC20180—
+2K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+2K113754CFR QuantUniversity of Texas Medical School AT Houston20129—
+2K033347Modification to: HI-Art SystemTomotherapy Incorporated200326—
+3K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+3K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+3K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+3K042739HI-Art SystemTomotherapy Incorporated200425—
+4K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+4K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+4K060912Modification to: HI-Art SystemTomotherapy Incorporated2006244
+5K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+5K192277CardIQ FlowGE Medical Systems SCS20200—
+5K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—
+5K082775Prescision OptionSiemens Medical Solutions USA, Inc.20099—
+5K082005Modification to HI-Art Treatment SystemTomotherapy Incorporated2008137
+6K112776Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated201111—
+6K112446Tomotherapy Treatment SystemTomotherapy Incorporated20110—
+6K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+6K092145160MLC OptionSiemens Medical Solutions USA, Inc.2009411
+6K090683Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc.200974
+7K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+7K123812Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens…Siemens Medical Solutions USA, Inc.201339
+7K121934Tomotherapy Treatment SystemAccuray Incorporated2012108
+7K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+7K102671Syngo RT Therapist Connect Workspace, V4.2Siemens Medical Solutions USA, Inc.20105—
+8K190978RefleXion Medical Radiotherapy SystemReflexion Medical, Inc.202001
+8K171837TomoTherapy Treatment Delivery System with iDMSAccuray Incorporated201701
+8K161136Precision Treatment Planning SystemAccuray Incorporated20162—
+8K161146Radixact Treatment Delivery SystemAccuray Incorporated201631
+8K152488Onrad Treatment SystemAccuray Incorporated20150—
+8K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+9K202412ClearRT Helical kVCT for the Radixact Treatment Delivery SystemAccuray Incorporated20201—
+9K182687Motion Tracking and Compensation Feature for the Radixact Treatment Delivery SystemAccuray Incorporated20180—
+9K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+9K171086Accuray Precision Treatment Planning SystemAccuray Incorporated20171—
+10K223159Radixact Treatment Delivery SystemAccuray Incorporated20230—
+10K212794Accuray Precision Treatment Planning SystemAccuray Incorporated20210—