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

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
Angiographic x-ray system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to an x-ray fluoroscopy based imaging system including x-ray angiography system configurations. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080506857
Device count
1

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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Primary DI, Brand, Company table
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B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.MQB2026-04-30
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.JAA2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.JAA2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.MQB2026-04-30
08809365280001SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08809365281015SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08809244060533GenorayGENORAY CO., LTD.JAA2026-04-10
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08809244060618GenorayGENORAY CO., LTD.JAA2025-12-01
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08800018422601EXTRON 3DRTECH CorporationJAA2025-06-17
08809244060090GenorayGENORAY CO., LTD.JAA2025-05-02
00190376601182IntraOp Alignment SystemALPHATEC SPINE, INC.JAA2024-10-01
00195278840233OptimaGE Hualun Medical Systems Co., LtdMQB2024-07-04
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00193982184506EXCELSIUS3DGLOBUS MEDICAL, INC.JAA2024-06-26
00193982184537EXCELSIUS3DGLOBUS MEDICAL, INC.JAA2024-06-26
088000186021950909FCCRayence Co., Ltd.MQB2024-03-21
088000186022010909FCC-HSRayence Co., Ltd.MQB2024-03-21