FDA.reportPublic FDA data

NA

Primary DI
00198953023266
Brand
NA
Company
GE Hualun Medical Systems Co., Ltd
Model
GCWS-C3
Device description
G3A standard Wallstand
Published
2025-02-28
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
IXYHolder, Radiographic Cassette, Wall-Mounted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXYHolder, Radiographic Cassette, Wall-MountedRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198953023266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198953023266001989530232661989530232660198953023266

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
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
00858340006547Del Medical, Inc.Del Medical, Inc.IXY2026-03-05
00198953043288NAGE Hualun Medical Systems Co., LtdIXY2025-04-22
00198953043295NAGE Hualun Medical Systems Co., LtdIXY2025-04-22
00198953023259NAGE Hualun Medical Systems Co., LtdIXY2025-02-28
08800018422502LLD 86 BasicDRTECH CorporationIXY2024-05-08
05999116186119Z-MOTION STANDCONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIXY2023-12-04
08809832900111SU-2100SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900128SU-4500SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900159LSS-1000SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900166SU-2000SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900173SD-3500SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900180SU-4000SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900197SD-6000SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08809832900241SD-6000SHINYOUNG FOR M CO.,LTD.IXY2023-11-20
08800018421307LLD 129 BasicDRTECH CorporationIXY2023-11-03
08800018421406LLD 129 without rotationDRTECH CorporationIXY2023-11-03
08800018421208DBS-57MDRTECH CorporationIXY2023-09-04
05999116100580WS99(N) WALL STANDCONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIXY2023-08-15
05055449402958KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXY2023-07-11
05055449415927KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXY2023-07-11
00858340006387Del Medical, Inc.Del Medical, Inc.IXY2023-05-16
08800018421000LLD 129 CompactDRTECH CorporationIXY2023-04-12
08800018421109LLD 129 SamsungDRTECH CorporationIXY2023-04-12
07350011170111! Mobile wallstandSolutions For Tomorrow ABIXY2023-03-09
B884SFS100L0FS 100 WallstandPausch, L.L.C.IXY2022-12-28
B884SFS100R0FS 100 WallstandPausch, L.L.C.IXY2022-12-28
05055449415705KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXY2022-12-08
05055449415910KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXY2022-12-08
05055449415934KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXY2022-12-08
08800018420706LLD 129 with rotationDRTECH CorporationIXY2022-11-29