Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033508292

FEI Number

3033508292

Entity Name

GE Vingmed Ultrasound AS

City/State/Country

Trondheim Trondelag, NO

Establishment Address

Prinsesse Kristinas Gate 3, Trondheim Trondelag 7030, NO

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

K202658

PMA Number

N/A

All Registered Proprietary Names

4Vc-D iC5-9-D 9L-D 11L-D C3-10-D P2D Vivid Pioneer M5Sc-D 9VT-D 6Sc-D C1-6-D 10-D 6VT-D 6S-D 12S-D 6Vc-D L8-18i-D C2-9-D 4Vc-D 6S-D 8C 6Tc-RS 9T-RS iC5-9-D M5Sc-D 12S-D 6VT-D C2-9-D 9L-D P6D 11L-D P2D C1-6-D 9T Vivid E95 Vivid E90 C3-10-D 10T-D Vivid E80 L8-18i-D EchoPAC Plug-in EchoPAC Connect EchoPAC Software Only EchoPAC Suite 12S-D 6VT-D L8-18i-D 4Vc-D IC5-9-D 6S-D C3-10-D P6D 11L-D M5Sc-D Vivid S70N Dimension C1-5-D 6Tc-RS ML6-15-D Vivid S70N C2-9-D P2D 9T-RS C1-6-D 9L-D 3Sc-RS Vivid S60N Vscan Air Vscan Air SL Vscan Air CL 9T C2-9-D ML6-15-D 9L-D Vivid E95 4Vc-D Vivid E80 4V-D M5Sc-D C3-10-D 9VT-D 10T-D 6S-D 6Vc-D P2D Vivid E90 8C iC5-9-D 6VT-D 12S-D L8-18i-D P6D 11L-D C1-6-D 9T-RS 6Tc-RS EchoPAC Connect EchoPAC Suite EchoPAC Plug-in EchoPAC EchoPAC Software Only P2D 9L-D 11L-D 4Vc-D Vivid S70N 6Tc-RS C3-10-D Vivid S60N 3Sc-RS ML6-15-D C1-5-D 6S-D C1-6-D 12S-D 9T-RS 6VT-D Vivid S70N Dimension P6D L8-18i-D IC5-9-D C2-9-D M5Sc-D M5Sc-D P6D 6VT-D Vivid S70N C2-9-D 9T-RS C1-5-D 12S-D IC5-9-D P2D ML6-15-D 6S-D 6Tc-RS Vivid S60N C3-10-D 11L-D L8-18i-D 9L-D C1-6-D 10T-D 4Vc-D 3Sc-RS 6Tc-RS 12S-D C2-9-D iC5-9-D 8C 9T-RS 9T P2D 11L-D Vivid E90 4V-D C1-6-D P6D L8-18i-D Vivid E95 6VT-D 9L-D 6S-D M5Sc-D Vivid E80 10T-D Vscan with Dual Probe Vscan Extend G3S, deep scanning transducer G8L, shallow scanning transducer Vscan Extend dual probe dual probe EchoPAC Plug-in EchoPAC Software Only C2-9-D M5Sc-D 9T-RS 6Tc-RS IC5-9-D C3-10-D 6S-D P6D 11L-D 9L-D 3Sc-RS Vivid S60N P2D C1-6-D 6VT-D Vivid S70N 12S-D 10T-D M5Sc-D 11L-D C2-9-D 6Tc-RS C3-10-D Vivid S70N P2D C1-5-D P6D 6VT-D 9T-RS Vivid S60N IC5-9-D L8-18i-D C1-6-D 10T-D 3Sc-RS 12S-D 9L-D Vscan Air CL Vscan Air 6VT-D Vscan Air CL Vscan Air SL Vscan Air Vscan Extend G3S, Deep Scanning Transducer G8L, Shallow Scanning Transducer Vscan Extend dual probe dual probe P6D 8C Vivid E95 11L-D C1-6-D L8-18i-D Vivid E80 9T C3-10-D 9T-RS C2-9-D 4V-D Vivid E90 M5Sc-D 6S-D 6Tc-RS P2D 9L-D iC5-9-D 12S-D 6VT-D P6D 11L-D 9T 9L-D 6VT-D 6S-D Vivid E80 P2D 8C M5Sc-D 6Tc-RS 9T-RS 4V-D 10T-D Vivid E90 C1-6-D 4Vc-D C2-9-D Vivid E95 C3-10-D iC5-9-D 12S-D L8-18i-D EchoPAC Software Only EchoPAC Plug-in iC5-9-D 6Vc-D ML6-15-D C2-9-D 8C 12S-D 4Vc-D P2D C1-6-D Vivid E80 C3-10-D 6Tc-RS 10T-D 4V-D 11L-D 9T-RS Vivid E90 L8-18i-D M5Sc-D 6S-D P6D Vivid E95 9T 9L-D 4D ICE catheter 6VT-D

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-08-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-08-04
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-08-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-11-07
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-11-07
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-11-07
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-07-26
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2022-07-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-07-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-07-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-07-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-09-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-09-21
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-09-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-07-25
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-07-25
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-07-25
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-07-21
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-07-21
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-02-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-02-21
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-02-21
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-06-29
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-06-29
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-06-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-03-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-03-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-03-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-06-02
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-06-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-06-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-09-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-09-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-09-08
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-06-15
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-06-19
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-06-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-06-19
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-11-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-11-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-11-02
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-12-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-12-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-12-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-08-05
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-05-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-05-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-05-02
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-06-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-06-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-06-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-06-15
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-06-15
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-06-15
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-10-31
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-10-31
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-10-31
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-09-21
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-03-11
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-03-11
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-03-11
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2021-03-11

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
K882805	Coopervision-Cilco	CILCO VILLASENOR PACHYMETER	1988-08-12
K791040	Shimadzu Corp.	SECTOR SCANNER, SDU-100, COMPUTERIZED	1979-10-04
K162372	Qt Ultrasound, LLC	QT Ultrasound Breast Scanner-1	2017-06-06
K930964	Acuson Corp.	ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)	1994-10-26
K052355	U-Systems, Inc.	AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS	2005-09-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011	Verathon, Inc.	2	AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011	Verathon, Inc.	2	BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014	SonoSite, Inc.	2	P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
Z-0009-2022	DJO, LLC	2	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND

Similar Registrations

Registration Number	Establishment Name	Location
3008515880	EZONO AG	Jena Thuringia, DE
3029744051	LYSIS HEALTHCARE GMBH	Graz Steiermark, AT
3014574557	ADECHOTECH	NAVEIL Loir-et-Cher, FR
3012081348	THE SENTINEL IMAGING GROUP, INC	Clarks Summit, PA, US
3025786376	ACO HEALTHCARE CO., LTD.	Taoyuan City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033508292. Last updated year: 2026. Please use registration number 3033508292 when referencing this establishment in official correspondence.