Home / 510(k) Clearances / K171086

510(k) K171086

Accuray Precision Treatment Planning System by Accuray Incorporated — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2017
Date Received
April 12, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Accuray Incorporated

  • K223159 — Radixact Treatment Delivery System (June 23, 2023)
  • K212794 — Accuray Precision Treatment Planning System (September 30, 2021)
  • K202412 — ClearRT Helical kVCT for the Radixact Treatment Delivery System (December 18, 2020)
  • K182687 — Motion Tracking and Compensation Feature for the Radixact Treatment Delivery Sys (November 23, 2018)
  • K171837 — TomoTherapy Treatment Delivery System with iDMS (July 25, 2017)
  • K161146 — Radixact Treatment Delivery System (June 24, 2016)
  • K161144 — iDMS Data Management System (June 24, 2016)
  • K161136 — Precision Treatment Planning System (June 24, 2016)
  • K152488 — Onrad Treatment System (September 28, 2015)
  • K150873 — CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System (July 1, 2015)

Other clearances for product code IYE

  • K252977 — Halcyon, Ethos Radiotherapy System (5.0) (January 21, 2026)
  • K252188 — EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infin (January 15, 2026)
  • K254010 — ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface (January 14, 2026)
  • K252988 — ChartCheck (RADCH V1.6) (January 5, 2026)
  • K252919 — IDENTIFY (5.0) (December 16, 2025)
  • K250392 — ZAP-X Radiosurgery System (ZAP-X) (November 3, 2025)
  • K250696 — AccuCheck (October 24, 2025)
  • K250911 — MOSkin Radiation Measurement System (October 17, 2025)
  • K252948 — TrueBeam, TrueBeam STX, Edge and VitalBeam (October 7, 2025)
  • K252174 — AquaCast Mask (September 3, 2025)