Radixact™ Treatment Delivery System N/A

GUDID M65810600000

Radixact Treatment Delivery System

ACCURAY INCORPORATED

Linear accelerator system
Primary Device IDM65810600000
NIH Device Record Keyc0e29cdd-62bd-4334-9488-5a311877b298
Commercial Distribution StatusIn Commercial Distribution
Brand NameRadixact™ Treatment Delivery System
Version Model Number1060000
Catalog NumberN/A
Company DUNS785961244
Company NameACCURAY INCORPORATED
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com
Phone4087164600
Emailwebhelp@accuray.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100811376030009 [Primary]
HIBCCM65810600000 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-26

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00811376030450 - CyberKnife® M6™ Systems2022-01-12 CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM) The CyberKnife M6 Systems are computer-c
00811376030467 - CyberKnife® M6™ Systems2022-01-12 CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM) The CyberKnife M6 Systems are computer-c

Trademark Results [Radixact]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RADIXACT
RADIXACT
86742946 5092439 Live/Registered
Accuray Incorporated
2015-08-31

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