Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008284470

FEI Number

3008284470

Entity Name

GE Healthcare (China) Co., Ltd.

City/State/Country

Beijing, CN

Establishment Address

1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area, Beijing 100176, CN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

GE HealthCare Technologies Inc. (Owner Number: 9912004)

Owner / Operator Contact Address

3000 N. Grandview Blvd, Waukesha, WI 53188, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K082816

PMA Number

N/A

All Registered Proprietary Names

Definium 8000 Discovery XR656 Discovery XR650 Optima XR640 NG2000 ELITE HEAVY TABLE GT1700V(GT1700V N9 ED3, GT1700V) VT1700V(GT1700V N9 ED3) GT1700V (GT1700V N9 ED3, GT1700V) VT1700 (GT1700 N9 ED3) VT2000X(GT2000x) Lite (LITE TABLE N9 ED3, Lite Table) NG 2000 Table NM/CT Patient Table VT2000 (GT2000 N9 ED3) Kunlun Table NG2000V table G3 RAD Elevation Table Standard table NG1700 Patient Table Table (Model: GCTBL-C4) Table (Model: GCTBL-C33) NG LITE 1700 (NG1700 ELITE STANDARD TABLE) NG2000SV Table NG LITE 2000 (NG2000 ELITE HEAVY TABLE) NG2000SV TABLE NG1700 ELITE STANDARD TABLE Radiographic Table (Model: VFTBL-1) NG1700SV Table Table (Model: GCTBL-C3333) NG1700SV TABLE SIGNA Sprint 1.5T AIR Posterior Array Revolution Ascend Sliding Optima CT660SE Optima CT660ProJ Optima CT660FREEdom Optima CT660Pro Optima CT660sPro Optima CT660J Optima CT660 Revolution EVO 33 kW/48 kW Optima CT660s Revolution EVO Revolution EVO EL Revolution EVO ES Revolution EVO EX Optima CT680 Expert Optima CT680 Quantum Optima CT 670 Optima CT680 Professional CT660 Cj2.5 Upgrade Console Generation Upgrade Optima XR646 HD Optima XR646 HD Upgrade SIGNA Voyager 1.5T TDI Posterior Array 1.5T Anterior Array 1.5T TDI Head Neck Array SIGNA Voyager Quantum Optima CT660sPro Optima CT660 Optima CT660s Optima CT660Pro Console Generation Upgrade Revolution Apex Select Revolution CT with Apex edition Revolution Apex Select with Elite Edition Revolution Apex Select with Plus Edition Revolution CT ES Revolution CT Power Revolution Apex Elite Revolution Apex Plus Revolution CT ES with Apex edition Optima CT680 Expert Revolution Maxima Revolution Ace Console Generation Upgrade Definium Tempo Select TDI POSTERIOR ARRAY TDI HEAD NECK ARRAY SIGNA Pioneer 3T AA 1.5T TDI Posterior Array 1.5T Anterior Array 1.5T TDI Head Neck Array Signa Voyager Premier Edition SIGNA Voyager Quantum SIGNA Voyager Table (Model: GCTBL-C44) SIGNA Prime Elite Auto Positioning Brivo XR385 Revolution ACT SIGNA Sprint Select Discovery XR656 with VolumeRAD Discovery XR656 MR Vectra Discovery XR656 HD with VolumeRad Definium Tempo Definium Tempo Pro Optima XR646 HD Upgrade Discovery XR656 HD Optima XR646 HD Discovery XR656 HD Upgrade INNOVA IGS 620 INNOVA 2121-IQ INNOVA 3131-IQ DISCOVERY IGS 730 INNOVA 4100-IQ INNOVA 2100-IQ Optima IGS 320 Optima CL323i Optima CL320i INNOVA 3100-IQ INNOVA IGS 630 Optima IGS 330 Innova IGS 5 3DXR Discovery IGS 7 OR Discovery IGS 7 Innova IGS 6 INNOVA IGS 540 INNOVA IGS 530 INNOVA IGS 520 Performix Plus LU43318ST LU8548STR Performix 40 Plus MAXIRAY 100 TH-M1 APOLLON Solarix 350 Brightspeed Performix HD 43318 45645 Performix Pulsar Performix VCT Plus Performix 40 LU45649ST LU45645STR Vamana Surgery MX100 FL MX135CT TH1.1 Maxiray MX100 FL Maxiray CT VCT MX200CT/Performix Ultra 5855555 LU45645 SB-80-200R Performix 160A LU8743STR Ergo MONOBLOCK Performix Pro VCT 100 LU45649 Maxiray MX100 RAD LU45649STR LU45645ST LU40782 Brivo OEC 2.2A X-ray Generator MX100 RAD LU8743ST Vamana RAD LU8548ST 40782 Performix HD Plus Artemis MX165 NP Quantix 160 Maxiray CT Ultra Performix HDw SIGNA Champion Lunar iDXA series Collimator Assembly X-Ray Collimator OEC Beam Limiting Device HELIOS Collimator Prodigy/DPX Series Collimator Assembly Wolverine Collimator Innova IGS 5 IGS WF BP Discovery IGS 7 Cardiac X-ray Analysis Innova IGS 3 3DXR IGS WF SP Innova IGS 6 Discovery IGS 7 OR Allia IGS 3 Allia IGS 7 Allia IGS 7 OR Allia IGS 5 Optima IGS Mega Optima IGS Ultra Discovery CT Revolution Frontier Revolution Frontier ES Discovery CT750 HD Revolution HD Revolution Frontier Gen 3_HD Refresh Package Revolution Discovery CT Definium 5000 OEC One OEC One CFD Definium Pace Select ET OEC One LightSpeed VCT Select LightSpeed VCT LightSpeed Pro32 RT Refresh Package Discovery RT SmartMAR Optima RT OPTIMA CT580 OPTIMA CT580 W OPTIMA CT580 RT Revolution RT DISCOVERY CT590 RT OEC Elite MiniView OEC One CFD OEC One ASD Revolution Vibe 3T Detachable Table 3T eXpress Table 1.5T eXpress Table 1.5T Detachable Table SIGNA Victor Definium Pace Select SIGNA Prime 3T AA TDI POSTERIOR ARRAY TDI HEAD NECK ARRAY SIGNA Pioneer OEC Elite MiniView LightSpeed VCT LightSpeed VCT XTe REPRESSING BELT-ROHS REPRESSING BELT-Standard table Compression Band (Model: 5794807) Repression Belt (B2100BLT) OVERHEAD TUBE SUSPENSION (OTS for Definium Tempo Pro and Definium Tempo) (Model: 5822306) OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-7) Tubestand (Model: GCTS-C1) OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-9) OVERHEAD TUBE SUSPENSION (OTS for Definium Tempo Pro and Definium Tempo) (Model: 5822306-1) OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-10) Tubestand (Model: GCTS-C11) OVERHEAD TUBE SUSPENSION (OTS for Discovery XR656 HD) (Model: 5135678-11) OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-8) IQST assembly Quality Care Suite 2 Discovery RT Discovery CT590 RT Optima CT580 W Optima CT580 Optima CT580 RT SIGNA Artist Evo SIGNA Artist LightSpeed VCT LightSpeed VCT Select LightSpeed VCT standard LightSpeed VCT XT LightSpeed Pro32 Optima Advance Revolution Advance Revolution Eagle Optima CT520 Proteus XR/a GE 8CH Foot Ankle Coil Operator Console for BrightSpeed Elite_BrightSpeed Elite Select Optima CT540

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2010-06-15
IZF	System, X-Ray, Tomographic	Radiology	Class 2	892.1740	2010-06-15
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2010-06-15
IZZ	Table, Radiographic, Non-Tilting, Powered	Radiology	Class 2	892.1980	2004-09-24
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2025-09-18
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-09-18
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2025-09-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-02-26
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-09-11
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2017-12-15
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2017-12-15
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2016-09-06
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2016-09-06
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-08-17
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-12-22
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-10-28
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2025-08-29
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2025-08-29
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2017-01-04
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2017-01-04
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2020-01-20
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2020-01-20
IXR	Table, Radiographic, Tilting	Radiology	Class 2	892.1980	2002-06-28
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2025-04-03
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-04-03
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2020-01-23
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2011-10-17
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-06-08
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2026-02-09
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2026-02-09
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2026-02-09
IZF	System, X-Ray, Tomographic	Radiology	Class 2	892.1740	2014-06-03
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2012-02-14
IZF	System, X-Ray, Tomographic	Radiology	Class 2	892.1740	2019-09-06
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-09-06
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2019-09-06
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2013-02-11
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2013-02-11
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2013-02-11
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	1999-10-06
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2024-01-25
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2024-01-25
IZW	Collimator, Automatic, Radiographic	Radiology	Class 2	892.1610	2014-12-02
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2018-11-07
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-11-07
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2018-11-07
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2018-11-07
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2012-10-09
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2012-01-09
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2012-01-09
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2018-11-26
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2018-11-26
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-11-26
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2024-10-28
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2024-10-28
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2017-11-14
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2017-11-14
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2017-11-14
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-09
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2014-05-05
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2017-07-14
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2017-07-14
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2025-01-03
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-01-03
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-01-03
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-08-05
KXJ	Table, Radiologic	Radiology	Class 2	892.1980	1998-08-17
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-02-21
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2023-09-15
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2023-09-15
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2022-01-17
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2015-07-23
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2015-07-23
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2016-06-23
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2016-06-23
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-09
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2018-11-05
IYB	Tube Mount, X-Ray, Diagnostic	Radiology	Class 1	892.1770	1978-03-16
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2009-04-30
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-05-06
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2022-03-07
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2022-03-07
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2022-03-07
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2020-09-24
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2020-09-24
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2020-09-24
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-09
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-02-27
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2007-11-05
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2012-11-28
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2010-06-09

Official Correspondent

No official correspondent registered.

US Agent Details

Tracey Holevas Business: GE HealthCare Technologies, Inc Email: tracey.holevas@gehealthcare.com Phone: (262) 3092157

Related Public Records

Same Entity

GE HealthCare Technologies Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3015060224	IMACTIS, SAS	SAINT MARTIN D'HERES, FR
2122726	GE MEDICAL SYSTEMS, LLC	Milwaukee, WI, US
9617766	GE BE PRIVATE LIMITED	WHITEFIELD, BANGALORE Karnataka, IN
9710090	GE ULTRASOUND KOREA, LTD.	Seongnam-Si Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04
K150150	Rayence Co., Ltd.	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	2015-03-27
K140771	Philips Medical Systems Dmc GmbH	PHILIPS ELEVA WORKSPOT	2014-04-25
K201670	Siemens Medical Solutions USA, Inc.	YSIO X.pree	2020-10-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2009	Toshiba American Medical Systems Inc	2	Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007	AGFA Corp.	2	CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-0002-2009	GE Medical Systems, LLC	2	Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434
Z-0002-2015	Siemens Medical Solutions USA, Inc	2	Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Z-0003-2009	GE Medical Systems, LLC	2	Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. Intended for use in generating Tomographic images of human anatomy.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008284470. Last updated year: 2026. Please use registration number 3008284470 when referencing this establishment in official correspondence.