FDA.report

Varex Imaging

Primary DI
08718755000818
Brand
Varex Imaging
Company
Varex Imaging Nederland B.V.
Model
50149-21-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 series
Published
2019-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IZWCollimator, Automatic, Radiographic

Product Code Classifications

CodeDeviceSpecialtyClass
IZWCollimator, Automatic, RadiographicRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08718755000818PrimaryGS10

GMDN Terms

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

Regulatory Flags

DUNS number
413223942
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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
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08718755004052Varex ImagingOPTICA10-00-001-005-OEM2022-09-23
08718755004069Varex ImagingOPTICA10-00-004-005-OEM2022-09-23
08718755003208Varex ImagingOPTICA10-01-065-001-OEM2022-04-04
08718755003215Varex ImagingOPTICA10-01-000-001-OEM2022-04-04
08718755003222Varex ImagingOPTICA10-01-001-001-OEM2022-04-04
08718755003239Varex ImagingOPTICA10-01-002-001-OEM2022-04-04
08718755003246Varex ImagingOPTICA10-01-003-001-OEM2022-04-04
08718755003253Varex ImagingOPTICA10-01-004-001-OEM2022-04-04
08718755003260Varex ImagingOPTICA10-01-005-001-OEM2022-04-04
08718755003277Varex ImagingOPTICA10-01-006-001-OEM2022-04-04
08718755003284Varex ImagingOPTICA10-01-007-001-OEM2022-04-04
08718755003291Varex ImagingOPTICA10-01-008-001-OEM2022-04-04

Other Devices Sharing Product Codes

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
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
08718755000870Varex 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
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
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
08718755000450ClaymountVarex Imaging Nederland B.V.IZW2017-04-14
08718755000467ClaymountVarex Imaging Nederland B.V.IZW2017-04-14
08718755000474ClaymountVarex Imaging Nederland B.V.IZW2017-04-14
08718755000481ClaymountVarex Imaging Nederland B.V.IZW2017-04-14