Medical Device Manufacturer · US , Sunnyvale , CA

Accuray Incorporated - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 2004

Recent clearances: Radixact Treatment Delivery System, Accuray Precision Treatment Planning System, ClearRT Helical kVCT for the Radixact Treatment Delivery System

21
Total
21
Cleared
0
Denied

Accuray Incorporated has 21 FDA 510(k) cleared radiology devices. Based in Sunnyvale, US.

Last cleared in 2023. Active since 2004.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Accuray Incorporated

21 devices
1-21 of 21
Cleared Jun 23, 2023
Radixact Treatment Delivery System
K223159 · IYE
Radiology · 259d
Cleared Sep 30, 2021
Accuray Precision Treatment Planning System
K212794 · IYE
Radiology · 28d
Cleared Dec 18, 2020
ClearRT Helical kVCT for the Radixact Treatment Delivery System
K202412 · IYE
Radiology · 116d
Cleared Nov 23, 2018
Motion Tracking and Compensation Feature for the Radixact Treatment Delivery...
K182687 · IYE
Radiology · 58d
Cleared Jul 25, 2017
TomoTherapy Treatment Delivery System with iDMS
K171837 · IYE
Radiology · 35d
Cleared Jun 08, 2017
Accuray Precision Treatment Planning System
K171086 · IYE
Radiology · 57d
Cleared Jun 24, 2016
Precision Treatment Planning System
K161136 · MUJ
Radiology · 63d
Cleared Jun 24, 2016
iDMS Data Management System
K161144 · IYE
Radiology · 63d
Cleared Jun 24, 2016
Radixact Treatment Delivery System
K161146 · IYE
Radiology · 63d
Cleared Sep 28, 2015
Onrad Treatment System
K152488 · MUJ
Radiology · 28d
Cleared Jul 01, 2015
CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System
K150873 · IYE
Radiology · 91d
Cleared Apr 14, 2015
Delivery Analysis
K143269 · MUJ
Radiology · 152d
Cleared Oct 26, 2012
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY...
K122137 · IYE
Radiology · 100d
Cleared Aug 29, 2012
TOMOTHERAPY TREATMENT SYSTEM
K121934 · IYE
Radiology · 58d
Cleared Mar 09, 2012
SYNCHRONY RESPIRATORY TRACKING SYSTEM
K120233 · IYE
Radiology · 44d
Cleared Nov 17, 2010
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K102650 · IYE
Radiology · 64d
Cleared Sep 21, 2007
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K072504 · IYE
Radiology · 15d
Cleared Aug 22, 2007
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K071531 · IYE
Radiology · 78d
Cleared Sep 28, 2006
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K062514 · MUJ
Radiology · 31d
Cleared Sep 14, 2005
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
K052325 · MUJ
Radiology · 20d
Cleared Sep 17, 2004
ROBOCOUCH PATIENT SUPPORT SYSTEM
K042146 · JAI
Radiology · 39d
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