Nexus DRF, Digital Imaging Software

GUDID 00854344007245

VAREX IMAGING CORPORATION

X-ray system computer, diagnostic, general-purpose
Primary Device ID00854344007245
NIH Device Record Key91a86972-bf06-47b9-a817-5ef128e55afc
Commercial Distribution StatusIn Commercial Distribution
Brand NameNexus DRF, Digital Imaging Software
Version Model Numberv3.1.1
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
GS100854344007245 [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 Date2019-06-24
Device Publish Date2019-06-14

On-Brand Devices [Nexus DRF, Digital Imaging Software]

00854344007245v3.1.1
00854344007474Nexus DRF v3.1.2

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