MRIdian Linac System

GUDID 00868029000346

VIEWRAY INCORPORATED

Stereotactic teletherapy radionuclide system, MRI-imaging
Primary Device ID00868029000346
NIH Device Record Key6b00966f-f2ef-44dc-af0b-9c2c68ae4cba
Commercial Distribution StatusIn Commercial Distribution
Brand NameMRIdian Linac System
Version Model Number20000-01
Company DUNS015705677
Company NameVIEWRAY INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100868029000346 [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 Date2022-05-16
Device Publish Date2022-05-06

Devices Manufactured by VIEWRAY INCORPORATED

00868029000308 - Head Neck Coil (Receive Only) – Bottom2022-05-16
00868029000315 - Medium Torso Coil (Receive Only) – Bottom2022-05-16
00868029000346 - MRIdian Linac System2022-05-16
00868029000346 - MRIdian Linac System2022-05-16
00868029000353 - Head Neck Coil (Receive Only) – Top2022-05-16
00868029000360 - Medium Torso Coil (Receive Only) – Top2022-05-16
00868029000391 - Head Coil (Receive Only)2022-05-16
00850036816027 - MRIdian A3i Software2022-05-13

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