FDA.reportPublic FDA data

InfiMed Digital Imaging System, i5, DSA, CCD Camera

Primary DI
00854344007009
Brand
InfiMed Digital Imaging System, i5, DSA, CCD Camera
Company
VAREX IMAGING CORPORATION
Model
i5 DSA
Published
2017-03-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZISystem, X-Ray, AngiographicRadiology2
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093066000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093066000I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5Infimed, Inc.2010-03-16OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854344007009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854344007009008543440070098543440070090854344007009

GMDN Terms#

Term, Definition table
TermDefinition
X-ray system computer, diagnostic, general-purposeA dedicated mainframe computer, personal computer (PC) or PC based platform and associated hardware, firmware, and operating system software used specifically to control and monitor the operation of a general-purpose medical x-ray system and associated image processing, display and analysis functions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080506857
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854344007658Varex Digital Imaging Software, Nexus DRv4.92021-08-06
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
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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