FDA.reportPublic FDA data

Artis one

Primary DI
04056869009964
Brand
Artis one
Company
Siemens Shenzhen Magnetic Resonance Ltd.
Model
10848600
Published
2016-09-24
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
JAASystem, x-ray, fluoroscopic, image-intensified
OWBInterventional fluoroscopic x-ray system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869009964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869009964040568690099644056869009964

GMDN Terms#

Term, Definition table
TermDefinition
Stationary angiographic x-ray system, digitalA stationary diagnostic fluoroscopic x-ray system specifically designed to optimize the capability of users to visually and quantitatively evaluate the anatomy and function of blood vessels of the heart, brain and other organs, as well as the lymphatic system. It uses digital techniques for real-time image capture, display and manipulation and typically includes spot-film capabilities in addition to the fluoroscopic features. It is commonly used in conjunction with an injected x-ray contrast medium during either imaging or x-ray guided surgical or interventional procedures. Images can be viewed in both real-time and delayed formats.

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 Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)888-7436XX@XX.XX
+1(800)888-7436CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
544891302
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056869997926MAGNETOM Flow.Plus115713122025-07-07
04056869997933MAGNETOM Flow.Plus115713132025-07-07
04056869281759MAGNETOM Free.Max114084242022-09-01
04056869281766MAGNETOM Free.Star114084262022-09-01
04056869281773MAGNETOM Free.Star114084272022-09-01
04056869281742MAGNETOM Free.Max114084252021-08-02
04056869996202MAGNETOM Flow.Ace115712472025-07-07
04056869996219MAGNETOM Flow.Ace115712482025-07-07
04056869281926Contour M Coil Set114076772022-09-01
04056869281858Head/Neck Coil114076592021-08-02
04056869281896Head/Neck Coil Set114076602021-08-02
04056869281933Spine Coil114073782021-08-02
04056869281940Spine Coil Set114073772021-08-02
04056869163383Shoulder Shape 16112928052021-07-30
04056869165325Shoulder Shape 16 Coil Set 1.5T112928062021-07-30
04056869231105Flex large 8112931342021-07-30
04056869231112Flex Large 8 Coil Set 1.5T112931332021-07-30
04056869231129BM Body 13114072552021-07-30
04056869231136BM Body 13 MR Coil Set 1.5T114072562021-07-30
04056869231167Flex Small 8 Coil Set 1.5T112931352021-07-30

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08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
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08809244060090GenorayGENORAY CO., LTD.JAA2025-05-02
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