FDA.reportPublic FDA data

NA

Primary DI
00198953043301
Brand
NA
Company
GE Hualun Medical Systems Co., Ltd
Model
GCTBL-C44
Device description
Radiographic Table
Published
2025-04-22
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
IXRTable, Radiographic, Tilting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXRTable, Radiographic, TiltingRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198953043301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198953043301001989530433011989530433010198953043301

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

Regulatory Flags#

DUNS number
554408665
Device count
1
Premarket exempt
true
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
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
07350006950148Sonesta F3Sonesta Medical ABIXR2025-10-14
07350006950049Sonesta F3Sonesta Medical ABIXR2025-09-30
00850061871015IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-04-03
00850061871022IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-04-03
00850061871008IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-02-23
00850977007997IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-02-23
00817463026405Oakworks MedicalOAKWORKS, INC.IXR2023-12-06
00817463026412Oakworks Medical OAKWORKS, INC.IXR2023-12-06
00817463026429Oakworks MedicalOAKWORKS, INC.IXR2023-12-06
00817463026436Oakworks MedicalOAKWORKS, INC.IXR2023-12-06
00817463026184Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026214Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026221Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026238Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026252Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026276Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026306Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026313Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463026320Oakworks MedicalOAKWORKS, INC.IXR2023-07-17
00817463025941Oakworks MedicalOAKWORKS, INC.IXR2023-07-11
00817463025972Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463025989Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026054Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026061Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026092Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026177Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026245Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026269Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026283Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026290Oakworks MedicalOAKWORKS, INC.IXR2023-07-10