FDA.reportPublic FDA data

Definium

Primary DI
00198953056158
Brand
Definium
Company
GE Hualun Medical Systems Co., Ltd
Model
Tempo Select
Catalog number
B4400UDI
Device description
Definium Tempo Select System UDI
Published
2026-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K250788000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250788000Definium Tempo SelectGe Hualun Medical Systems Co. , Ltd.2025-08-28KPR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198953056158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198953056158001989530561581989530561580198953056158

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.

Regulatory Flags#

DUNS number
554408665
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682146197RevolutionACT LMB2019-07-25
00840682116701FlashPad5340000-82016-08-01
00840682116732FlashPad5340000-72016-08-01
00198953056103DefiniumPace Select ETB4600UDI2026-02-12
00840682145541OECOne CFD2019-08-09
00198953054949NAGCTS-C112025-09-30
00195278913814DefiniumTempo SelectB2400UDI2025-09-05
00840682121071Flashpad HD43432019-06-27
00195278901880NAGCTS-C12025-06-09
00195278840226DiscoveryXR656 HD Upgrade2024-07-04
00195278840233OptimaXR646 HD Upgrade2024-07-04
00840682136709DiscoveryXR656 HD Upgrade2018-01-29
00840682142168OptimaXR646 HD Upgrade2018-11-14
00195278832252NAVMWS-22024-07-01
00195278713759NAVMWS-1VMWS-12023-09-18
00195278713766NAVFTBL-1VFTBL-12023-09-18
00840682145503D630 UpgradeH2401XFH2401XF2021-04-30
00840682120777ProteusXRa2016-08-01
00840682138925NAB2100BLT2018-11-13
00840682138932NA57948072018-11-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
08800011121280FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121297FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121303FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121310FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121327FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121334FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121341FDR ClinicaDRGEM CorporationKPR2019-11-20