FDA.reportPublic FDA data

NA

Primary DI
00195278012258
Brand
NA
Company
GE Hualun Medical Systems Co., Ltd
Model
6788888-3
Device description
G4 Table HLA
Published
2020-11-24
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
IZZTable, radiographic, non-tilting, powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZZTable, Radiographic, Non-Tilting, PoweredRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195278012258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278012258001952780122581952780122580195278012258

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(999)999-9999xx@xx.xx

Regulatory Flags#

DUNS number
554408665
Device count
1
Serial number
true
Manufacturing date on label
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
00198953056158DefiniumTempo SelectB4400UDI2026-02-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800011101145DRGEMDRGEM CorporationIZZ2025-02-11
05999116100023PHOENIX 1CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIZZ2024-10-30
S062110000ElevatorMaxPausch, L.L.C.IZZ2024-04-24
05999116100054PHOENIX 2CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIZZ2023-08-15
B884S06211100L0CombiMaxPausch, L.L.C.IZZ2022-12-28
B884S06211100R0CombiMaxPausch, L.L.C.IZZ2022-12-28
00195278527455NAGE Hualun Medical Systems Co., LtdIZZ2022-07-21
00858340006134Del Medical, Inc.Del Medical, Inc.IZZ2022-04-15
00840682140942NAGE Hangwei Medical Systems Company Ltd.IZZ2018-11-09
00840682141895NAGE Hangwei Medical Systems Company Ltd.IZZ2018-11-09
00840682141932NAGE Hualun Medical Systems Co., LtdIZZ2018-11-06
60889978606801DRX - Ascend SystemCARESTREAM HEALTH, INC.IZZ2018-01-15
00850977007058IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007065IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007072IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007089IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007096IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007188IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007195IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007201IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007218IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00850977007225IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-09-18
00840682102674NAGE Hangwei Medical Systems Company Ltd.IZZ2017-07-28
00840682103572NAGE Healthcare Japan CorporationIZZ2017-07-17
08800011101008DRGEMDRGEM CorporationIZZ2017-05-29
08800011101015DRGEMDRGEM CorporationIZZ2017-05-29
08800011101022DRGEMDRGEM CorporationIZZ2017-05-29
08800011100018DRGEMDRGEM CorporationIZZ2017-05-29
00850977007171IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-05-18
00850977007041IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IZZ2017-02-02