FDA.reportPublic FDA data

Mobilett Mira Max

Primary DI
04056869009131
Brand
Mobilett Mira Max
Company
Siemens Healthcare GmbH
Model
10594738
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
K111912000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111912000MOBILETT MIRASiemens Medical Solutions USA, Inc.2011-09-19IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869009131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869009131040568690091314056869009131

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.

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
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
08800040900252AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900269AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900276AirRay-miniPoskom Co., Ltd.IZL2026-04-15
00850079606043MC2 Portable X-ray SystemOXOS Medical, Inc.IZL2026-03-25
00850079606050EmitterOXOS Medical, Inc.IZL2026-03-25
04547410571134FDR AQROFUJIFILM CORPORATIONIZL2026-03-20
00858340006479Del Medical, Inc.Del Medical, Inc.IZL2026-03-05
08800060100229REMEX Xcam6REMEDI CO.,LTD.IZL2026-01-22