Radixact Treatment Delivery System NA

GUDID 00811376030047

Radixact Treatment Delivery System, Version 2.0. (including Base System, kV, and Synchrony)

ACCURAY INCORPORATED

Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system
Primary Device ID00811376030047
NIH Device Record Keyb5c4e894-8385-4e2b-9cac-9fcaa9c332c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameRadixact Treatment Delivery System
Version Model Number1080200
Catalog NumberNA
Company DUNS785961244
Company NameACCURAY INCORPORATED
Device Count1
DM Exemptfalse
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

Phone408-716-4600
Emailwebhelp@accuray.com
Phone408-716-4600
Emailwebhelp@accuray.com
Phone408-716-4600
Emailwebhelp@accuray.com
Phone408-716-4600
Emailwebhelp@accuray.com
Phone408-716-4600
Emailwebhelp@accuray.com
Phone408-716-4600
Emailwebhelp@accuray.com
Phone408-716-4600
Emailwebhelp@accuray.com
Phone408-716-4600
Emailwebhelp@accuray.com
Phone408-716-4600
Emailwebhelp@accuray.com
Phone408-716-4600
Emailwebhelp@accuray.com
Phone408-716-4600
Emailwebhelp@accuray.com
Phone408-716-4600
Emailwebhelp@accuray.com
Phone408-716-4600
Emailwebhelp@accuray.com
Phone408-716-4600
Emailwebhelp@accuray.com
Phone408-716-4600
Emailwebhelp@accuray.com
Phone408-716-4600
Emailwebhelp@accuray.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100811376030047 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-10
Device Publish Date2019-05-31

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