FDA.reportPublic FDA data

Varex Imaging

Primary DI
08718755002713
Brand
Varex Imaging
Company
Varex Imaging Nederland B.V.
Model
ICX989B
Device description
An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposure Control (AEC) in delivering the proper x-ray dose in medical radiography.This is a device out of the Ionization Chambers series.
Published
2022-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IZOGenerator, High-Voltage, X-Ray, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZOGenerator, High-Voltage, X-Ray, DiagnosticRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08718755002713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718755002713087187550027138718755002713

GMDN Terms#

Term, Definition table
TermDefinition
Ionization chamber radiation measuring probeAn electrically isolated or electronically connected gas-filled radiation detection chamber operated in the "ionization chamber" voltage region. It is used with portable survey meters, stationary radiation monitors or analytical counting instruments. The incident radiation sets up a characteristic "saturated current" within the chamber. A number of probes with different size chambers and chamber wall thicknesses are needed to cover the possible range of radiation energies and doses. It is very stable over time and may be used for accurate dosimetry measurements, e.g., source calibrations and inter-comparisons. For accurate measurements, temperature and pressure corrections are needed.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
413223942
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08718755004106Varex ImagingSolidStateMC 5022025-09-30
08718755004113Varex ImagingSolidStateMC 5062025-09-30
08718755004144Varex ImagingSolidStateMC 5212025-09-30
08718755004168Varex ImagingSolidStateMC 6052025-09-30
08718755004182Varex ImagingSolidStateMC 6102025-09-30
08718755004199Varex ImagingSolidStateMC 6132025-09-30
08718755004205Varex ImagingSolidStateMC 6142025-09-30
08718755004212Varex ImagingSolidStateMC 6162025-09-30
08718755004243Varex ImagingSolidStateMC 6212025-09-30
08718755004120Varex ImagingSolidStateMC 5082025-09-30
08718755004137Varex ImagingSolidStateMC 5102025-09-30
08718755004151Varex ImagingSolidStateMC 6012025-09-30
08718755004175Varex ImagingSolidStateMC 6092025-09-30
08718755004229Varex ImagingSolidStateMC 6172025-09-30
08718755004236Varex ImagingSolidStateMC 6192025-09-30
08718755004250Varex ImagingSolidStateMC 6252025-09-30
08718755004090Varex ImagingSolidStateMC 5012025-09-17
08718755004052Varex ImagingOPTICA10-00-001-005-OEM2022-09-23
08718755004069Varex ImagingOPTICA10-00-004-005-OEM2022-09-23
08718755003208Varex ImagingOPTICA10-01-065-001-OEM2022-04-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00055846500108Epsilon High Voltage GeneratorEMD TechnologiesIZO2026-01-12
00055846500115Epsilon High Voltage GeneratorEMD TechnologiesIZO2026-01-12
00055846500122Epsilon High Voltage GeneratorEMD TechnologiesIZO2026-01-12
08718755004106Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004113Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004144Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004168Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004182Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004199Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004205Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004212Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004243Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004120Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004137Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004151Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004175Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004229Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004236Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004250Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-30
08718755004090Varex ImagingVarex Imaging Nederland B.V.IZO2025-09-17
06973858210492Medical X-ray High Frequency High Voltage GeneratorSuzhou Powersite Electric Co., LTDIZO2025-05-29
08800011110437DRGEMDRGEM CorporationIZO2025-05-28
08800011110444DRGEMDRGEM CorporationIZO2025-05-28
08800011110451DRGEMDRGEM CorporationIZO2025-05-28
08800011110468DRGEMDRGEM CorporationIZO2025-05-28
08800011110475DRGEMDRGEM CorporationIZO2025-05-28
08800011110482DRGEMDRGEM CorporationIZO2025-05-28
08800011110499DRGEMDRGEM CorporationIZO2025-05-28
08800011110505DRGEMDRGEM CorporationIZO2025-05-28
08800011110512DRGEMDRGEM CorporationIZO2025-05-28