510(k) Report

Devices descending from K082005

13 later devices reach Modification to HI-Art Treatment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112776Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated201111—
+1K112446Tomotherapy Treatment SystemTomotherapy Incorporated20110—
+2K121934Tomotherapy Treatment SystemAccuray Incorporated2012108
+3K190978RefleXion Medical Radiotherapy SystemReflexion Medical, Inc.202001
+3K171837TomoTherapy Treatment Delivery System with iDMSAccuray Incorporated201701
+3K161136Precision Treatment Planning SystemAccuray Incorporated20162—
+3K161146Radixact Treatment Delivery SystemAccuray Incorporated201631
+3K152488Onrad Treatment SystemAccuray Incorporated20150—
+4K202412ClearRT Helical kVCT for the Radixact Treatment Delivery SystemAccuray Incorporated20201—
+4K182687Motion Tracking and Compensation Feature for the Radixact Treatment Delivery SystemAccuray Incorporated20180—
+4K171086Accuray Precision Treatment Planning SystemAccuray Incorporated20171—
+5K223159Radixact Treatment Delivery SystemAccuray Incorporated20230—
+5K212794Accuray Precision Treatment Planning SystemAccuray Incorporated20210—