FDA.reportPublic FDA data

X-ray Beam Filter Kit

Primary DI
40889978154117
Brand
X-ray Beam Filter Kit
Company
CARESTREAM HEALTH, INC.
Model
X-ray Beam Filter Kit
Catalog number
8154114
Device description
4X4 X-ray Beam Filter Kit
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KPWDevice, beam limiting, x-ray, diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPWDevice, Beam Limiting, X-Ray, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K837334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K837334000X-RAY BEAM FILTEREastman Kodak Company1983-04-22

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60889978154111PackageGS120In Commercial Distribution
40889978154117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6088997815411160889978154111
4088997815411740889978154117

GMDN Terms#

Term, Definition table
TermDefinition
X-ray/radiation therapy beam filter, sheetA device used with a diagnostic or therapeutic x-ray system consisting of single/compound metal composition sheets that are designed to be placed in the path of the x-ray beam before it reaches the patient (target). It is typically made of aluminium, copper, tin or a combinations of these. Diagnostic and therapeutic x-ray systems typically have a designated slot located in the x-ray tube assembly where it can be inserted and interchanged. In diagnostic x-ray the filter removes low energy radiation before reaching the patient to protect from useless radiation. In therapeutic applications, it reduces low-energy photons delivered to the patient managing beam quality and adequate irradiation.

Regulatory Flags#

DUNS number
793169512
Device count
1
Lot or batch
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
04589607250019NAYOSHIDA DENZAI KOGYO CO., LTD.KPW2017-09-13
04987670101670X-ray beam limiting deviceCANON INC.KPW2017-04-11
04056869011554Collimator ML01 IISiemens Healthcare GmbHKPW2017-02-02
04056869011578Collimator AL02 II eLSiemens Healthcare GmbHKPW2016-10-23
08057737120015Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAKPW2016-09-24
08057737120114Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAKPW2016-09-24
08057737120213Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAKPW2016-09-24
08057737120312Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAKPW2016-09-24
08057737120411Philips Medical Systems DMCVILLA SISTEMI MEDICALI SPAKPW2016-09-24
60889978154111X-ray Beam Filter KitCARESTREAM HEALTH, INC.KPW2016-09-16
08058776050141Ralco srlRALCO SRLKPW2016-08-05
08058776050158Ralco srlRALCO SRLKPW2016-08-05
08058776050189Ralco srlRALCO SRLKPW2016-08-05
08058776050011Ralco srlRALCO SRLKPW2016-08-04
08058776050028Ralco srlRALCO SRLKPW2016-08-04
08058776050066Ralco srlRALCO SRLKPW2016-08-04
08058776050073Ralco srlRALCO SRLKPW2016-08-04
08058776050097Ralco srlRALCO SRLKPW2016-08-04
08058776050103Ralco srlRALCO SRLKPW2016-08-04
08058776050134Ralco srlRALCO SRLKPW2016-08-04