Varex Digital Imaging Software, Nexus DR, v4.13

GUDID 00854344007726

VAREX IMAGING CORPORATION

X-ray system computer, diagnostic, general-purpose
Primary Device ID00854344007726
NIH Device Record Key0238f8ce-8636-4d56-bb35-2b7e7b1c6109
Commercial Distribution StatusIn Commercial Distribution
Brand NameVarex Digital Imaging Software, Nexus DR, v4.13
Version Model NumberNexus DR, v4.13
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100854344007726 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-07
Device Publish Date2023-05-30

On-Brand Devices [Varex Digital Imaging Software, Nexus DR, v4.13]

00854344007726Nexus DR, v4.13
00854344007733Nexus DR, v4.14

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