510(k) Report

Devices descending from K150873

9 later devices reach CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171804Zap-X Radiosurgery SystemZap Surgical Systems20173—
+1K170788CyberKnife Treatment Delivery SystemAccuray Incorportaed201704
+1K161136Precision Treatment Planning SystemAccuray Incorporated20162—
+1K161144iDMS Data Management SystemAccuray Incorporated20160—
+2K183698Zap-X Radiosurgery SystemZap Surgical Systems20192—
+2K171086Accuray Precision Treatment Planning SystemAccuray Incorporated20171—
+3K212794Accuray Precision Treatment Planning SystemAccuray Incorporated20210—
+3K211663Zap-X Radiosurgical SystemZap Surgical Systems, Inc.202112
+4K250392ZAP-X Radiosurgery System (ZAP-X)Zap Surgical Systems, Inc.20250—