FDA.reportPublic FDA data

Ralco srl

Primary DI
08058776050172
Brand
Ralco srl
Company
RALCO SRL
Model
R 302 ACS/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
IZWCollimator, Automatic, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZWCollimator, Automatic, RadiographicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058776050172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058776050172080587760501728058776050172

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.

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
08058776050066Ralco srlR 221/A DHHS2016-08-04
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
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
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