FDA.reportPublic FDA data

NA

Primary DI
00840682103572
Brand
NA
Company
GE Healthcare Japan Corporation
Model
5121647-4
Device description
GT2000 N9 ED3 ASSY
Published
2017-07-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00840682103572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682103572008406821035728406821035720840682103572

GMDN Terms#

Term, Definition table
TermDefinition
CT system tableA powered/programmable table that has electronic and/or software controls for table top height and positioning and is specifically designed to position and support a patient during diagnostic examinations involving the use of an x-ray computed tomography (CT) system; it is not primarily intended for interventional procedures/surgery. It is typically an integral component of a CT system design or gantry configuration and can be flat or curved and made of radiolucent materials with low x-ray attenuation coefficients.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
696021596
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682116817NAIC5-9-D 54923512016-07-15
00840682110631NAC2-9VN-D2016-07-15
00840682106870NA12L-RS2016-07-15
00840682106962NA8C-RS2016-07-15
00840682110655NAC3-10-D2016-07-15
00840682106528NAIC5-9H2016-07-15
00840682110877NAM4S-D2016-07-15
00195278723963NA6Sc-DH46462LS2025-10-15
00195278718129RevolutionAscend EliteRevolutionAscendElite2024-04-25
00195278718136RevolutionAscend PlusRevolutionAscendPlus2024-04-25
00195278718204RevolutionAscend SelectRevolutionAscendSelect2024-04-25
00195278620453DLIR1.259288632023-06-30
00195278303196ASiR-V1.12021-08-25
00195278303202DLIR1.12021-08-25
00195278303219MAR1.12021-08-25
00840682146173RevolutionAscendRevolutionAscend2020-11-26
00840682104401NASIGNA Pioneer2016-08-01
00840682106573NA8C2016-07-15
00840682106627NAE8C2016-07-15
00840682106702NAE8C-RS-LC2016-07-15

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
00195278012258NAGE Hualun Medical Systems Co., LtdIZZ2020-11-24
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
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