Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613445

FEI Number

3002175190

Entity Name

GE HANGWEI MEDICAL SYSTEMS CO., LTD.

City/State/Country

Beijing, CN

Establishment Address

West Area of Building No.3, No.1 Yongchang North Road, Beijing Economic and Technological Development Area, Beijing 100176, CN

Establishment Type(s)

Manufacture Medical Device

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

K132261

PMA Number

N/A

All Registered Proprietary Names

OEC Elite MiniView 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 Xeleris 4 Processing and Review Workstation Xeleris 4 DR Processing and Review Workstation REPRESSING BELT-ROHS REPRESSING BELT-Standard table Compression Band (Model: 5794807) Repression Belt (B2100BLT) Revolution ACT TrueFidelity Deep Learning Image Reconstruction (DLIR) OEC One OEC One CFD OEC One CFD OEC One ASD Definium Tempo Select Collimator Collimator X-Ray Brivo XR285amx Optima XR220amx Optima XR200amx Optima CT680 Expert Revolution Maxima Revolution Ace Console Generation Upgrade True Enhance DL Discovery RT Discovery CT590 RT Optima CT580 W Optima CT580 Optima CT580 RT Max Apollo + Max Elite + Omni Legend Definium Pace Select ET IQST assembly Quality Care Suite 2 OEC One CFD Lunar Astra 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 Enhanced Extream Injector Option Extream Injector Option Proteus XR/a Lunar iDXA series Collimator Assembly X-Ray Collimator OEC Beam Limiting Device HELIOS Collimator Prodigy/DPX Series Collimator Assembly Wolverine Collimator Optima XR646 HD Optima XR646 HD Upgrade Discovery CT Revolution Frontier Revolution Frontier ES Discovery CT750 HD Revolution HD Revolution Frontier Gen 3_HD Refresh Package Revolution Discovery CT Wallstand (GCMWS-C5) WALL MOUNTED CASSETTE HOLDER Wallstand for X-Ray System Wallstand (Model: VMWS-1; VMWS-2) Wallstand (Model: GCEWS-C4) Wallstand (Model: GCWS-C3; GCWS-C5; GCWS-C6) Revolution Ascend ES Revolution Ascend EX Revolution Ascend Revolution Ascend EL Revolution Ascend Plus Revolution Ascend Elite Revolution Ascend Select 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 Revolution CT with Apex Edition Revolution CT Revolution Apex Revolution CT ES Revolution CT ES with Apex edition Revolution Apex Plus Brivo XR385 Brivo NM 615 Aurora Xeleris V Processing and Review System Definium 8000 Discovery XR656 Discovery XR650 Optima XR640 NM 830 Discovery NM 630 OEC One True Definitional DL Revolution UPG 5 Discovery XR656 HD Discovery XR656 HD Upgrade 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 Definium Pace Select 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) Aurora Deep Learning Image Reconstruction for Gemstone Spectral Imaging SmartView 3D Option Discovery MI Gen 2 Discovery MI Gen2 Discovery Max Pro Discovery Future Discovery Power NM/CT 860 NM/CT 850 NM/CT 850 CT system NM/CT 860 CT system Table (Model: GCTBL-C44) Revolution Ascend Sliding Discovery XR656 with VolumeRAD Discovery XR656

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	1999-10-06
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-03-31
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2018-11-05
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-06-08
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-04-23
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
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
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
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2011-06-27
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-10-28
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-04-12
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2011-05-06
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-08-12
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2024-08-12
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
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2009-04-30
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2025-12-22
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-12-22
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-12-22
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-12-22
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2026-06-18
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	2010-06-09
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2007-11-05
IZW	Collimator, Automatic, Radiographic	Radiology	Class 2	892.1610	2014-12-02
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
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2012-10-09
IXY	Holder, Radiographic Cassette, Wall-Mounted	Radiology	Class 1	892.1880	1978-02-22
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-02-07
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2013-09-11
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-07-30
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2011-10-17
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2012-01-11
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2012-01-11
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2025-06-16
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-06-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-04-24
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
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2011-07-07
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	2026-03-26
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2017-10-25
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2017-10-25
IZZ	Table, Radiographic, Non-Tilting, Powered	Radiology	Class 2	892.1980	2004-09-24
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
IYB	Tube Mount, X-Ray, Diagnostic	Radiology	Class 1	892.1770	1978-03-16
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-02-19
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2025-02-19
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2020-12-15
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2017-01-16
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2021-08-23
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-08-23
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2018-04-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-04-18
IXR	Table, Radiographic, Tilting	Radiology	Class 2	892.1980	2002-06-28
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-02-26
IZF	System, X-Ray, Tomographic	Radiology	Class 2	892.1740	2014-06-03

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
K863853	Superior Medical Products	EAZY COVERS	1987-03-06
K953974	Medivision Medical Imaging, Ltd.	CAMVISION 1000	1996-09-09
K024012	Ge Oec Medical Systems	OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM	2003-03-20
K970608	Guidant Cardiac and Vascular Surgery	EVT MARKER BOARD	1997-04-21
K203010	Apelem-Dms Group	Platinum dRF Imaging System	2021-01-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2007	GE OEC Medical Systems, Inc	2	GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0001-2009	Philips Medical Systems North America Co. Phillips	2	NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Z-0004-2010	Ge Healthcare	2	GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
Z-0005-2010	Ge Healthcare	2	GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.
Z-0009-04	Siemens Medical Solutions USA, Inc	2	Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Motor Drive

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3033527282	Philips India Limited - Image Guided Therapy Systems Business Unit	Bengaluru Karnataka, IN
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613445. Last updated year: 2026. Please use registration number 9613445 when referencing this establishment in official correspondence.