FDA.reportPublic FDA data

Varex Digital Imaging Software, Nexus DR

Primary DI
00854344007658
Brand
Varex Digital Imaging Software, Nexus DR
Company
VAREX IMAGING CORPORATION
Model
v4.9
Device description
Digital image acquisition system designed to automate patient work flow that includes image processing algorithms for imaging.
Published
2021-08-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854344007658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854344007658008543440076588543440076580854344007658

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular fluoroscopy/intravascular imaging softwareA software program intended to display and analyse/process images of the heart and/or blood vessels (e.g., coronary, intracranial, peripheral) acquired during a fluoroscopic x-ray (angiography) and/or intravascular imaging procedure [typically intravascular ultrasound and/or optical coherence tomography (OCT)], to assist with diagnosis, treatment, and/or an implantation procedure [e.g., aortic heart valve replacement, embolization device or stent implantation, by generating computed tomography-like (CT) images via fluoroscopy]. It does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

Phone, Email table
PhoneEmail
801-978-5399victor.garcia@vareximaging.com

Regulatory Flags#

DUNS number
080506857
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08718755003574Varex ImagingICX307D2025-02-25
08718755002584Varex ImagingICX307C2022-03-04
00854344007757Varex Digital Imaging Software, Nexus DR, v4.16Nexus DR, v4.162024-06-21
00854344007740Varex Digital Imaging Software, Nexus DR, v4.15Nexus DR, v4.152024-03-11
00854344007733Varex Digital Imaging Software, Nexus DR, v4.13Nexus DR, v4.142023-09-18
00854344007610Varex Digital Imaging Software, Nexus DRF, v3.6Nexus DRF v3.62023-05-30
00854344007672Varex Digital Imaging Software, Nexus DR, v4.10Nexus DR, v4.102023-05-30
00854344007696Varex Digital Imaging Software, Nexus DR, v4.12Nexus DR, v4.122023-05-30
00854344007726Varex Digital Imaging Software, Nexus DR, v4.13Nexus DR, v4.132023-05-30
00854344007474Nexus DRF, Digital Imaging Softwarev3.1.22019-09-20
00854344007245Nexus DRF, Digital Imaging Softwarev3.1.12019-06-14
00854344007429Varex Digital Imaging System, Nexus, DRF, v3.1.0Nexus DRF v3.1.02019-04-16
00854344007443Varex Digital Imaging System, Nexus, DRF, v3.2.0Nexus DRF v3.2.02019-04-16
00854344007009InfiMed Digital Imaging System, i5, DSA, CCD Camerai5 DSA2017-03-24
00854344007016Varex Digital Imaging Software, Nexus, DR, v3.1Nexus, DR, v3.12017-06-07
00854344007023Varex Digital Imaging Software, Nexus, DRF, v2.5Nexus, DRF, v2.52017-12-11
00854344007047InfiMed Digital Imaging System, i5, DR, Digital Receptori5 DR2017-03-24
00854344007061InfiMed Digital Imaging System, i5, RF, CCD Camerai5 RF2017-03-24
00854344007078InfiMed Digital Imaging System, Nexus, RF/DR, Non Varian Digital ReceptorNexus DRF (RF/DR)2017-03-24
00854344007085InfiMed Digital Imaging System, Platinum One, RF, CCD CameraPlatinum One RF2017-03-24

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