FDA.reportPublic FDA data

Mobilett XP

Primary DI
04056869009087
Brand
Mobilett XP
Company
Siemens Healthcare GmbH
Model
01818363
Device description
Mobile Generator
Published
2016-09-24
Public version status
Update
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033238000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033238000MOBILETTE XP AND MOBILETT XPHYBRIDSiemens Medical Systems, Inc.2003-11-14IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869009087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869009087040568690090874056869009087

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
313217003
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04068151027273myAblation Guide10831405108314052026-08-06
04056869991771myAblation Guide108313732026-05-11
04068151018226syngo Application Software118312342026-05-15
04056869964539syngo Application Software300002672024-11-15
04056869964546syngo Application Software300002662024-01-01
04056869262567syngo Application Software113281802022-10-10
04056869247144syngo Dynamics VA20G107456502019-09-04
04056869247175syngo Dynamics VA20G Packaging Label107456532019-09-04
04056869274645AI-Rad Companion Organs RT115452902021-08-06
04056869257969AI-Rad Companion Organs RT112944332021-02-18
04056869272313syngo Dynamics115521032020-10-29
04056869272320syngo Dynamics115521022020-10-29
04056869256399syngo Dynamics115516432020-07-14
04056869259901syngo Dynamics115518642020-07-14
04056869248653syngo.Interventional113279882020-01-13
04056869124162syngo Application Software113276672020-01-10
04056869253244syngo Dynamics107459602019-12-12
04056869096506syngo.plaza112937242019-05-01
04056869001081syngo.plaza110644362016-09-23
04056869004365syngo.plaza112499522016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014490156EUROPAAspen Imaging Healthcare IncIZL2026-10-16
00850079606081MC2 Portable X-ray SystemOXOS Medical, Inc.IZL2026-09-21
00850079606098EmitterOXOS Medical, Inc.IZL2026-09-21
00850079606104CassetteOXOS Medical, Inc.IZL2026-09-21
00860014490163APX-24Aspen Imaging Healthcare IncIZL2026-09-08
00860015436306EUROPAAspen Imaging Healthcare IncIZL2026-09-08
00860015436313EUROPAAspen Imaging Healthcare IncIZL2026-09-08
00860015436320EUROPAAspen Imaging Healthcare IncIZL2026-09-08
08800098700187XLITEGEMSS Healthcare Co., Ltd.IZL2026-08-26
G221500MC009H0iQ FlexFirst Source, Inc.IZL2026-08-25
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
08800011150129DRGEMDRGEM CorporationIZL2026-05-20
08800011150136DRGEMDRGEM CorporationIZL2026-05-20
07350011170005TrueMobileSolutions For Tomorrow ABIZL2026-05-18
08800184900002X-RAYNEUF Inc.IZL2026-05-11
08800184900019X-RAYNEUF Inc.IZL2026-05-11
08908021109097PRORAD ATLAS ULTRAPORTABLEPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-05-07
08908021109103PRORAD ATLAS ULTRAPORTABLE PLUSPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-04-16
08800040900108Diagnostic X-ray UnitPoskom Co., Ltd.IZL2026-04-15
08800040900221Airbile-100Poskom Co., Ltd.IZL2026-04-15
08800040900245AirRay-miniPoskom Co., Ltd.IZL2026-04-15