FDA.reportPublic FDA data

X-ray beam limiting device

Primary DI
04987670101670
Brand
X-ray beam limiting device
Company
CANON INC.
Model
BLR-15AA
Published
2017-04-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K133553000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133553000KALAREToshiba America Medical Systems, In.C2014-06-13JAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987670101670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987670101670049876701016704987670101670

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

Contacts#

Phone, Email table
PhoneEmail
+1-8004211968xxx@xxx.xxx

Regulatory Flags#

DUNS number
690549662
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987670100222INTERVENTIONAL ANGIOGRAPHY SYSTEMINFX-8000V2016-09-01
049876701013594ch Flex SPEEDERMJAJ-197A2016-09-01
04987670102493Vitrea Software Toshiba PackageVSTP-001A2018-03-02
04987670103360Vantage OrianMRT-15502018-11-30
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCUS-AME002026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCUS-ABE002026-06-01
04987670105579Aquilion ONETSX-308A2025-01-09
04987670103797CT SCANNERTSX-306A2021-11-01
04987670100741DIAGNOSTIC ULTRASOUND SYSTEMTUS-X100S2016-09-01
04987670100734DIAGNOSTIC ULTRASOUND SYSTEMTUS-X1002016-09-01
04987670100758DIAGNOSTIC ULTRASOUND SYSTEMTUS-X2002016-09-01
04987670100765DIAGNOSTIC ULTRASOUND SYSTEMTUS-X200S2016-09-01
04987670106095Aquilion Serve SPTSX-307B2024-07-04
04987670102721PHASED ARRAY TRANSDUCERPSU-60ST2026-03-01
04987670102745LINEAR ARRAY TRANSDUCERPLU-1003ST2026-03-01
04987670102752LINEAR ARRAY TRANSDUCERPLU-805ST2026-03-01
04987670102769PHASED ARRAY TRANSDUCERPSU-30ST2026-03-01
04987670102783LINEAR ARRAY TRANSDUCERPLU-704ST2026-03-01
04987670102806CW DOPPLER PENCIL TRANSDUCERPC-20ST2026-03-01
04987670102813DIAGNOSTIC ULTRASOUND SYSTEMTUS-VC1002026-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04589607250019NAYOSHIDA DENZAI KOGYO CO., LTD.KPW2017-09-13
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
40889978154117X-ray Beam Filter KitCARESTREAM HEALTH, INC.KPW2016-09-16
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