FDA.reportPublic FDA data

Ralco srl

Primary DI
08058776050066
Brand
Ralco srl
Company
RALCO SRL
Model
R 221/A DHHS
Published
2016-08-04
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
KPWDevice, Beam Limiting, X-Ray, Diagnostic

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058776050066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058776050066080587760500668058776050066

GMDN Terms#

Term, Definition table
TermDefinition
Manual-aperture-control diagnostic x-ray system collimator, non-motorizedA standard, non-motorized, diagnostic x-ray beam-limiting device whose aperture size/length/shutter assembly must be manually adjusted in order to match the size of the x-ray beam to the size of the x-ray cassette in use. It includes designs with manual controls that operate one or more shutter pairs and also designs that require the addition or removal of attachments or extensions that allow the operator to alter the size and shape of the exit beam from a cone or cylinder. An x-ray collimator 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.

Regulatory Flags#

DUNS number
428769327
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08058776050004Ralco srlP 225 ACS DHHS2016-08-05
08058776050011Ralco srlR 72 DHHS2016-08-04
08058776050028Ralco srlR 72 S DHHS2016-08-04
08058776050035Ralco srlR 108 DHHS2016-08-04
08058776050042Ralco srlR 108 F DHHS2016-08-04
08058776050059Ralco srlR 221 ACS DHHS2016-08-05
08058776050073Ralco srlP 232 DHHS2016-08-04
08058776050080Ralco srlR 225 ACS DHHS2016-08-04
08058776050097Ralco srlR 225 DHHS2016-08-04
08058776050103Ralco srlR 302/A DHHS2016-08-04
08058776050110Ralco srlP 313/A DHHS2016-08-04
08058776050127Ralco srlR 302/144/A DHHS2016-08-04
08058776050134Ralco srlR 302 L/A DHHS2016-08-04
08058776050141Ralco srlR 302 MLP/A DHHS2016-08-05
08058776050158Ralco srlR 302 MLPI/A DHHS2016-08-05
08058776050165Ralco srl R 302 DACS/A DHHS2016-08-04
08058776050172Ralco srlR 302 ACS/A DHHS2016-08-04
08058776050189Ralco srlR 302 DMLP DHHS2016-08-05
08058776050196Ralco srlR 605 DASM DHHS2016-08-04
08058776050219Ralco srlR 915 S DHHS2016-08-05

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
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
08058776050073Ralco srlRALCO SRLKPW2016-08-04
08058776050097Ralco srlRALCO SRLKPW2016-08-04
08058776050103Ralco srlRALCO SRLKPW2016-08-04
08058776050134Ralco srlRALCO SRLKPW2016-08-04