FDA.reportPublic FDA data

InfiMed Digital Imaging System, Precision RXi, RF/DSA, CCD Camera

Primary DI
00854344007092
Brand
InfiMed Digital Imaging System, Precision RXi, RF/DSA, CCD Camera
Company
VAREX IMAGING CORPORATION
Model
Precision RXi D
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
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012490000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012490000ORION DIGITAL IMAGING SYSTEMInfimed, Inc.2002-02-12OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854344007092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854344007092008543440070928543440070920854344007092

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
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
00854344007658Varex Digital Imaging Software, Nexus DRv4.92021-08-06
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

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