Varex Digital Imaging Software, Nexus DR

GUDID 00854344007658

Digital image acquisition system designed to automate patient work flow that includes image processing algorithms for imaging.

VAREX IMAGING CORPORATION

Angiographic x-ray system application software
Primary Device ID00854344007658
NIH Device Record Key09ee00ee-b952-442d-81d9-f34f70b4d0da
Commercial Distribution StatusIn Commercial Distribution
Brand NameVarex Digital Imaging Software, Nexus DR
Version Model Numberv4.9
Company DUNS080506857
Company NameVAREX IMAGING CORPORATION
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone801-978-5399
Emailvictor.garcia@vareximaging.com
Phone801-978-5399
Emailvictor.garcia@vareximaging.com
Phone801-978-5399
Emailvictor.garcia@vareximaging.com
Phone801-978-5399
Emailvictor.garcia@vareximaging.com
Phone801-978-5399
Emailvictor.garcia@vareximaging.com
Phone801-978-5399
Emailvictor.garcia@vareximaging.com
Phone801-978-5399
Emailvictor.garcia@vareximaging.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100854344007658 [Primary]

FDA Product Code

JAASystem, X-Ray, Fluoroscopic, Image-Intensified

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-16
Device Publish Date2021-08-06

Devices Manufactured by VAREX IMAGING CORPORATION

00810751030252 - Varex Digital Imaging Software, Nexus DRF, v3.52024-07-16
00854344007757 - Varex Digital Imaging Software, Nexus DR, v4.162024-07-01
00854344007740 - Varex Digital Imaging Software, Nexus DR, v4.152024-03-19
00854344007733 - Varex Digital Imaging Software, Nexus DR, v4.132023-09-26
00854344007610 - Varex Digital Imaging Software, Nexus DRF, v3.62023-06-07
00854344007634 - Varex Digital Imaging Software, Nexus, DRF, v3.72023-06-07
00854344007672 - Varex Digital Imaging Software, Nexus DR, v4.102023-06-07
00854344007696 - Varex Digital Imaging Software, Nexus DR, v4.122023-06-07

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