FDA.reportPublic FDA data

LINEAR IV

Primary DI
60889976568811
Brand
LINEAR IV
Company
CARESTREAM HEALTH, INC.
Model
LINEAR IV
Catalog number
6573778
Device description
R40-CS-P LIN IV COLLIMATOR W/65 FT CABLE
Published
2016-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K810598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K810598000X-RAY COLLIMATING DEVICESMidmark Corp.1981-04-10IZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60889976568811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6088997656881160889976568811

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
793169512
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
60889978624188DRX-Compass X-ray SystemDRX-Compass X-ray System86241812022-01-11
60889971739193DRX-Evolution Plus SystemDRX-Evolution Plus System17391922016-09-16
60889978007257DRX-Revolution Mobile X-ray SystemDRX-Revolution Mobile X-ray System80072542016-09-16
60889976565667CARESTREAM DRX-EVOLUTIONCARESTREAM DRX-EVOLUTION65656672016-09-16
40889971067506CS 7200CS 720010675032016-09-16
40889971067513CS 7200CS 720010675112016-09-16
40889971337227CS 7400CS 740013372292016-09-16
40889978214231CS 7400CS 740082142312016-09-16
40889978427969CS 7400CS 740084279652016-09-16
40889978666948CS 7400CS 740086669432016-09-16
60889976579336Vita Flex CR SystemVita Flex CR System65793382019-08-03
60889976579343Vita Flex CR SystemVita Flex CR System65793462019-08-03
60889976579367Vita Flex CR SystemVita Flex CR System65793612019-08-03
60889971746337Vita Flex CR Long Length Imaging SystemVita Flex CR Long Length Imaging System17463382020-05-25
60889971006240Vita LE CR SystemVita LE CR System10062462016-09-16
60889971014306CS 7600CS 760010143072016-09-16
60889971014313CS 7600CS 760010143152016-09-16
60889971023704CS 7600 SLOT PANELCS 7600 SLOT PANEL10237042016-09-16
60889971023711CS 7600 SLOT PANELCS 7600 SLOT PANEL10237122016-09-16
60889971024084Vita CR SystemVita CR System10240822016-10-03

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