FDA.reportPublic FDA data

MOBILETT Impact

Primary DI
04056869297309
Brand
MOBILETT Impact
Company
Siemens Healthcare GmbH
Model
11647500
Published
2025-11-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZLSystem, x-ray, mobile
KPRSystem, x-ray, stationary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2
KPRSystem, X-Ray, StationaryRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231577000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231577000MOBILETT ImpactSiemens Medical Solutions2023-07-25IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869297309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869297309040568692973094056869297309

GMDN Terms#

Term, Definition table
TermDefinition
Mobile basic diagnostic x-ray system, digitalAn assembly of devices that comprise a digital general-purpose mobile diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation and the mobile design allows it to operate on mains or battery power and to be driven or pushed by an operator to various locations within a building or facility. It is commonly used for bedside imaging and for interventional and intraoperative imaging. It consists of basic modular configurations that can be upgraded. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
313217003
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04068151012453syngo.CT Coronary Cockpit11664855116648552026-07-17
04068151027280syngo.via RT Image Suite VC10VC10VC102026-06-24
04068151034189AI-Rad Companion Organs RT11830482118304822026-06-23
04056869993973LUMINOS Q.namix R11574002115740022025-07-30
04056869993980LUMINOS Q.namix T11574003115740032025-07-30
04056869987187MAMMOMAT B.brilliant11372950113729502024-04-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IZL2026-07-10
08800017000107DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000114DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000121DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000138DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08683161912041GR10XXERA TEKNOLOJI VE YAZILIM LIMITED SIRKETIKPR2026-06-22
08683161912058GR10XXERA TEKNOLOJI VE YAZILIM LIMITED SIRKETIKPR2026-06-22
08436046003651SEDECALSEDECALIZL2025-03-21
08436046003668SEDECALSEDECALIZL2025-03-21
08436046003675SEDECALSEDECALIZL2025-03-21
08436046003682SEDECALSEDECALIZL2025-03-21
08436046003699SEDECALSEDECALIZL2025-03-21
08436046003705SEDECALSEDECALIZL2025-03-21
08436046003712SEDECALSEDECALIZL2025-03-21
08436046003729SEDECALSEDECALIZL2025-03-21
G221200CA3080iQ ViewFirst Source, Inc.IZL2023-06-13
08436046003101SEDECALSEDECALIZL2022-10-31
08436046003118SEDECALSEDECALIZL2022-10-31
08436046003125SEDECALSEDECALIZL2022-10-31
08436046003132SEDECALSEDECALIZL2022-10-31
08436046003149SEDECALSEDECALIZL2022-10-31