Varex Digital Imaging Software, Nexus, DR, v3.1

GUDID 00854344007016

VAREX IMAGING CORPORATION

X-ray system computer, diagnostic, general-purpose
Primary Device ID00854344007016
NIH Device Record Keyde7a2735-d712-4baf-8af6-478667d1b36d
Commercial Distribution StatusIn Commercial Distribution
Brand NameVarex Digital Imaging Software, Nexus, DR, v3.1
Version Model NumberNexus, DR, v3.1
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 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
GS100854344007016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

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 Date2017-06-07

Devices Manufactured by VAREX IMAGING CORPORATION

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
00854344007726 - Varex Digital Imaging Software, Nexus DR, v4.132023-06-07
08718755002461 - Varex Imaging2022-03-14 An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposur

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