Accuray Incorporated
Accuray Incorporated holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2023, with 22 FDA device recalls on record.
Top product codes for Accuray Incorporated
FDA recalls by Accuray Incorporated
10 most recent of 22- Z-2644-2026 — Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
- Z-2640-2026 — Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
- Z-1023-2025 — CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
- Z-2489-2023 — Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
- Z-1272-2021 — CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
- Z-0785-2021 — TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
- Z-0784-2021 — TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
- Z-0408-2019 — CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
- Z-3211-2018 — Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
- Z-1696-2019 — CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System f) 053501-010: CyberKnife Matrix Tier 2 TDS
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Accuray Incorporated
- K223159 — Radixact Treatment Delivery System
- K212794 — Accuray Precision Treatment Planning System
- K202412 — ClearRT Helical kVCT for the Radixact Treatment Delivery System
- K182687 — Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System
- K171837 — TomoTherapy Treatment Delivery System with iDMS
- K171086 — Accuray Precision Treatment Planning System
- K161136 — Precision Treatment Planning System
- K161144 — iDMS Data Management System
- K161146 — Radixact Treatment Delivery System
- K152488 — Onrad Treatment System
- K150873 — CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System
- K143269 — Delivery Analysis
- K122137 — CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM
- K121934 — TOMOTHERAPY TREATMENT SYSTEM
- K120233 — SYNCHRONY RESPIRATORY TRACKING SYSTEM
- K102650 — CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
- K072504 — CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
- K071531 — MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
- K062514 — CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
- K052325 — CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
- K042146 — ROBOCOUCH PATIENT SUPPORT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.