FDA.reportPublic FDA data

Collimator ML01 II

Primary DI
04056869011554
Brand
Collimator ML01 II
Company
Siemens Healthcare GmbH
Model
10092611
Published
2017-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869011554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869011554040568690115544056869011554

GMDN Terms#

Term, Definition table
TermDefinition
Manual-aperture-control diagnostic x-ray system collimator, motorizedA standard, diagnostic x-ray beam-limiting and shaping device with a motorized shutter/length adjustment mechanism that requires the operator to manually adjust the collimator shutters or length of the cone prior to an exposure in order to match the size and shape of the x-ray beam to the size of the x-ray cassette in use. Most motorized collimator assemblies include a light-centring device. 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999XX@XX.XX
+1(999)999-9999CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
313217003
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056869009179Multitom Rax10860700108607002016-09-24
04068151011807ARTIS icono.explore floor118320002026-05-15
04068151018226syngo Application Software118312342026-05-15
04068151033779ARTIS genio floor118321002026-05-15
04056869991771myAblation Guide108313732026-05-11
04056869295923ARTIS icono ceiling113281002022-10-01
04056869263168NAEOTOM Alpha113300032021-10-13
04056869063317ARTIS icono biplane113276002020-01-10
04056869149325ARTIS icono floor113277002020-01-10
04056869046877ARTIS pheno108490002017-05-15
04068151033977AI-Rad companion Brain MR118304812026-04-14
04068151020076syngo Dynamics117081242026-03-19
04056869973371AI-Rad Companion Organs RT116655082025-04-30
04068151036749MAGNETOM Flow.Rise117884172026-01-20
04056869299556MAGNETOM Flow.Neo115698352026-01-19
04056869299594MAGNETOM Flow.Neo115698392026-01-19
04068151034196MAGNETOM Flow.Elite118519112026-01-19
04068151036732MAGNETOM Flow.Elite118519122026-01-19
04068151047943MAGNETOM Flow.Neo118783442026-01-19
04068151047950MAGNETOM Flow.Elite118783452026-01-19

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
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