Collimator Cradle 512 asm

Primary DI
00884838081093
Brand
Collimator Cradle 512 asm
Company
Philips Digital Mammography Sweden AB
Model
1024280
Device description
The collimator is intended for a larger compression height range with breasts of larger size.
Published
2016-09-19
Public version status
Update
Distribution status
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130704000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130704000MICRODOSE SIPhilips Digital Mammography Sweden AB2013-12-13MUE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838081093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838081093008848380810938848380810930884838081093

GMDN Terms#

Term, Definition table
TermDefinition
Fixed-aperture diagnostic x-ray system collimatorA standard, non-motorized, diagnostic x-ray beam-limiting device that has a fixed size opening. It attaches by means of a slot or base plate to a diagnostic x-ray system tube housing and 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. An aperture diaphragm consists of a sheet of lead with a hole in the middle. The size and shape of the hole determine the size and shape of the x-ray beam exiting from the x-ray system. Cones and cylinders used for beam collimation are made of lead and attach by means of a base plate to an x-ray tube housing assembly.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
632899233
Device count
1
DM exempt
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838070943MicroDose SIL507140482016-08-31
00884838071001MicroDose SIL507142482016-09-23

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
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
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