FDA.reportPublic FDA data

Definium

Primary DI
00840682104364
Brand
Definium
Company
GE Medical Systems, L.L.C.
Model
5000
Device description
Definium 5000 480V Base System
Published
2016-08-01
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
KPRSystem, x-ray, stationary
MQBSolid state x-ray imager (flat panel/digital imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPRSystem, X-Ray, StationaryRadiology2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063283000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063283000DEFINIUM 5000 X-RAY SYSTEMSedecal., Sa.2006-11-17MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682104364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682104364008406821043648406821043640840682104364

GMDN Terms#

Term, Definition table
TermDefinition
Stationary basic diagnostic x-ray system, digitalAn assembly of devices that comprise general-purpose stationary 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. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(262)544-3011xx@xx.xx

Regulatory Flags#

DUNS number
144879404
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682138796Revolution160mm Detector Upgrade2018-01-11
00198953085950PhotonovaSpectra5590000-502026-05-11
00198953081839NA6265300-602026-04-02
00198953081877NA6265300-622026-04-02
00840682120784Flashpad HD25302017-07-28
00840682120807Flashpad HD35432017-07-28
00840682103053DiscoveryPETCT 6102016-08-01
00840682143974O560 to 610 Upgrade5607000-22018-12-05
00840682145749OptimaXR240amx HD Upgrade Gen22019-07-15
10840682142875Discovery PET CT690 VCT Boost Upgrade2018-11-16
00840682102490RevolutionDiscovery CT2016-06-08
00840682102995DiscoveryPETCT 7102016-08-01
00840682103107DiscoveryIQ2016-08-01
00840682108218DiscoveryMI2016-10-11
00840682115261OptimaXR220amx2016-08-01
00840682115278OptimaXR200amx2016-08-01
00840682119238Precision500D2016-08-01
00840682119658NA54216982016-08-01
00840682120975DiscoveryMI Digital Ready2016-10-11
00840682122351OptimaXR240amx2017-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057737122040Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08057737122057Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08800011150129DRGEMDRGEM CorporationMQB2026-05-20
08800011150136DRGEMDRGEM CorporationMQB2026-05-20
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
08800011150112DRGEMDRGEM CorporationMQB2025-08-26
07899581344695EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaMQB2023-12-08
07899581344701EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaMQB2023-12-08
07899581340253Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340260Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340277Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340284Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340697Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340727Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
08056600520051Nical Flat PanelNICAL SPAMQB2023-10-09
08057737122217Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2023-08-29
08057737122262Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2023-08-29
04056869951386MULTIX Impact ESiemens Shanghai Medical Equipment Ltd.KPR2022-09-26
04056869279985MULTIX ImpactSiemens Shanghai Medical Equipment Ltd.KPR2021-04-20
04056869262147MULTIX Impact CSiemens Shanghai Medical Equipment Ltd.KPR2021-03-22
08436046003026SEDECALSEDECALKPR2021-02-15
08436046003033SEDECALSEDECALKPR2021-02-15
08436046002388SEDECALSEDECALMQB2020-11-20
08436046002517SEDECALSEDECALMQB2020-05-29
08436046002456SEDECALSEDECALMQB2019-11-30
08800011121235FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121242FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121259FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121266FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121273FDR ClinicaDRGEM CorporationKPR2019-11-20