Accuray Inc

FDA Filings

This page includes the latest FDA filings for Accuray Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USANASDAQARAYDUNS 785961244
FDA Registration(s)
Registration Number3009813196
FEI Number3003873069
NameAccuray Incorporated
Owner & OperatorAccuray Incorporated
Contact Address1209 Deming Way --
Madison WI 53717 US
Official Correspondent
  • Daniel Biank
  • 1-608-8242971-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1240 Deming Way
Madison, WI 53717 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number1000123585
FEI Number1000123585
NameACCURAY INCORPORATED
Owner & OperatorAccuray Incorporated
Contact Address1209 Deming Way --
Madison WI 53717 US
Official Correspondent
  • Daniel Biank
  • 1-608-8242971-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1310 CHESAPEAKE TERRACE
Sunnyvale, CA 94089 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number3003873069
FEI Number3003873069
NameAccuray Incorporated
Owner & OperatorAccuray Incorporated
Contact Address1209 Deming Way --
Madison WI 53717 US
Official Correspondent
  • Daniel Biank
  • 1-608-8242971-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1209 DEMING WAY
MADISON, WI 53717 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Accuray Incorporated
ClearRT Helical KVCT For The Radixact Treatment Delivery System2020-12-18
ACCURAY INCORPORATED
Accuray Precision Treatment Planning System NA2020-05-05
ACCURAY INCORPORATED
Delivery Analysis NA2020-02-19
ACCURAY INCORPORATED
Accuray Precision Treatment Planning System NA2019-06-10
ACCURAY INCORPORATED
iDMS Data Management System NA2019-06-10
ACCURAY INCORPORATED
Radixact Treatment Delivery System NA2019-06-10
ACCURAY INCORPORATED
Motion Tracking And Compensation Feature For The Radixact Treatment Delivery System2018-11-23
ACCURAY INCORPORATED
Radixact™ Treatment Delivery System N/A2018-07-06
ACCURAY INCORPORATED
CyberKnife® Treatment Delivery System N/A2018-07-06
ACCURAY INCORPORATED
CyberKnife® Treatment Delivery System NA2018-07-06
Accuray Incorporated
TomoTherapy Treatment Delivery System with iDMS2017-08-29
Accuray Incorporated
TomoTherapy Treatment Delivery System with iDMS2017-08-29
Accuray Incorporated
Onrad? Treatment System2017-08-29
Accuray Incorporated
Onrad? Treatment System2017-08-29
Accuray Incorporated
Delivery Analysis2017-08-29
Accuray Incorporated
Delivery Analysis2017-08-29
Accuray Incorporated
Delivery Analysis2017-08-29
Accuray Incorporated
Delivery Analysis2017-08-29
Accuray Incorporated
TomoTherapy Treatment Delivery System With IDMS2017-07-25
Accuray Incorporated
Accuray Precision? Treatment Planning System2017-07-13
ACCURAY INCORPORATED
Accuray Precision? Treatment Planning System2017-07-13
Accuray Incorporated
Accuray Precision? Treatment Planning System2017-07-13
ACCURAY INCORPORATED
Accuray Precision? Treatment Planning System2017-07-13
Accuray Incorporated
CyberKnife? Treatment Delivery System2017-07-13
ACCURAY INCORPORATED
CyberKnife? Treatment Delivery System2017-07-13
Accuray Incorporated
Accuray Precision Treatment Planning System2017-06-08
Accuray Incorporated
Radixact Treatment Delivery System2016-12-06
Accuray Incorporated
Radixact Treatment Delivery System2016-12-06
Accuray Incorporated
TomoTherapy Treatment System (TomoH, TomoHD, TomoHDA)2016-12-06
Accuray Incorporated
TomoTherapy Treatment System (TomoH, TomoHD, TomoHDA)2016-12-06
Accuray Incorporated
TomoTherapy Treatment System (TomoH, TomoHD, TomoHDA)2016-12-06
Accuray Incorporated
TomoTherapy Treatment System (TomoH, TomoHD, TomoHDA)2016-12-06
Accuray Incorporated
iDMS Data Management System2016-11-28
ACCURAY INCORPORATED
iDMS Data Management System2016-11-28
ACCURAY INCORPORATED
Radixact Treatment Delivery System2016-06-24
ACCURAY INCORPORATED
IDMS Data Management System2016-06-24
ACCURAY INCORPORATED
Precision Treatment Planning System2016-06-24
ACCURAY INCORPORATED
Onrad Treatment System2015-09-28
Accuray Incorporated
CyberKnife M6 Series (FM, FI, FI+, FIM, F Neuro)2015-07-28
ACCURAY INCORPORATED
CyberKnife M6 Series (FM, FI, FI+, FIM, F Neuro)2015-07-28
ACCURAY INCORPORATED
CyberKnife VSI Robotic Radiosurgery System2015-07-28
ACCURAY INCORPORATED
CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System2015-07-01
ACCURAY INCORPORATED
Delivery Analysis2015-04-14
ACCURAY INCORPORATED
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM2012-10-26
ACCURAY INCORPORATED
TOMOTHERAPY TREATMENT SYSTEM2012-08-29
ACCURAY INCORPORATED
SYNCHRONY RESPIRATORY TRACKING SYSTEM2012-03-09
ACCURAY INCORPORATED
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM2010-11-17
ACCURAY, INC.
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM2009-05-01
ACCURAY, INC.
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY2004-06-10
ACCURAY, INC.
CYBERKNIFE SYSTEM2001-08-10
ACCURAY, INC.
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.12000-04-19
ACCURAY, INC.
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY1999-07-14

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092236305Shanghai ,China (Mainland) -> Los Angeles, CaliforniaCBL ASSY CAN HTR ROBOT BASE CBL ASSY ROBOT HEAD AND POWER ASSY CBL MGMT TRTMNT RBT MATRI3 PKG
2020091479720Kaohsiung,China (Taiwan) -> Long Beach, CaliforniaRETURN DEFECTED MEDICAL PARTS7 PKG
2020082461431Pusan,South Korea -> Los Angeles, CaliforniaUSED PARTS FOR TOMO THERAPY HI-ART SYSTEM 9022.9025 PKG
2020082235381Kaohsiung,China (Taiwan) -> Long Beach, CaliforniaT-PO-095963 PRIMARY COLLIMATOR CASTING IV NO. .2 WDC
2020082156280Kaohsiung,China (Taiwan) -> Long Beach, CaliforniaRETURN DEFECTED MEDICAL PARTS4 CTN
2020081563774Kaohsiung,China (Taiwan) -> Long Beach, CaliforniaT-PO-095963 PRIMARY COLLIMATOR CASTING IV NO. .2 WDC
2020081351590Shanghai ,China (Mainland) -> Los Angeles, CaliforniaELECTRIC CABLE4 CAS
2020080861619Kaohsiung,China (Taiwan) -> Long Beach, CaliforniaRETURN DEFECTED MEDICAL PARTS10 PKG

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