FDA.reportPublic FDA data

Varex Imaging

Primary DI
08718755000870
Brand
Varex Imaging
Company
Varex Imaging Nederland B.V.
Model
50149-24-OEM
Device description
x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(Collimator)This is a device out of the Optica 40 serie
Published
2019-07-23
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
IZWCollimator, Automatic, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZWCollimator, Automatic, RadiographicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08718755000870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718755000870087187550008708718755000870

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-aperture-control diagnostic x-ray system collimatorA standard, diagnostic x-ray beam-limiting and shaping device that includes an automatically controlled motorized shutter mechanism. It is designed to adjust the shutters so that the x-ray beam shape matches the size of the film cassette in the holder and is attached to the beam exit port of a diagnostic x-ray system tube housing assembly. It typically includes a light-centring device that is used to project a light field onto the patient that is coincident with the x-ray beam in order to centre the tube over the film cassette. It is used to limit the effects of scattered radiation on image quality and to provide patient protection by eliminating exposure to non-target body areas.

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
06975501940282iRayiRay Imaging Technology (Haining) LimitedIZW2024-07-20
08718755002232Varex ImagingVarex Imaging Nederland B.V.IZW2022-02-07
08718755002249Varex ImagingVarex Imaging Nederland B.V.IZW2022-02-07
08718755002379Varex ImagingVarex Imaging Nederland B.V.IZW2022-02-07
08718755002386Varex ImagingVarex Imaging Nederland B.V.IZW2022-02-07
04540217062447R-300SHIMADZU CORPORATIONIZW2020-04-03
04540217062454R-300SHIMADZU CORPORATIONIZW2020-04-03
04540217062461R-300SHIMADZU CORPORATIONIZW2020-04-03
08718755000849Varex ImagingVarex Imaging Nederland B.V.IZW2019-07-23
08718755000856Varex ImagingVarex Imaging Nederland B.V.IZW2019-07-23
08718755000863Varex ImagingVarex Imaging Nederland B.V.IZW2019-07-23
08718755000887Varex ImagingVarex Imaging Nederland B.V.IZW2019-07-23
08718755001396Varex ImagingVarex Imaging Nederland B.V.IZW2019-07-23
08718755001402Varex ImagingVarex Imaging Nederland B.V.IZW2019-07-23
08718755001426Varex ImagingVarex Imaging Nederland B.V.IZW2019-07-23
08718755000801Varex ImagingVarex Imaging Nederland B.V.IZW2019-07-19
08718755000818Varex ImagingVarex Imaging Nederland B.V.IZW2019-07-19
08718755000825Varex ImagingVarex Imaging Nederland B.V.IZW2019-07-19
08718755000832Varex ImagingVarex Imaging Nederland B.V.IZW2019-07-19
08718755001419VareximagingVarex Imaging Nederland B.V.IZW2019-07-12
08718755000795Varex ImagingVarex Imaging Nederland B.V.IZW2019-07-09
00840682122603not applicableGE MEDICAL SYSTEMSIZW2017-09-13
08718755000573ClaymountVarex Imaging Nederland B.V.IZW2017-06-12
08718755000580ClaymountVarex Imaging Nederland B.V.IZW2017-06-12
08718755000597ClaymountVarex Imaging Nederland B.V.IZW2017-06-12
08718755000603ClaymountVarex Imaging Nederland B.V.IZW2017-06-12
08718755000610ClaymountVarex Imaging Nederland B.V.IZW2017-06-12
08718755000429ClaymountVarex Imaging Nederland B.V.IZW2017-04-14
08718755000436ClaymountVarex Imaging Nederland B.V.IZW2017-04-14
08718755000443ClaymountVarex Imaging Nederland B.V.IZW2017-04-14