GE Vingmed Ultrasound AS

FDA Device Registration & Listing · Oslo, NO · Registration 3032807464

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3032807464
FEI Number
3032807464
Entity Name
GE Vingmed Ultrasound AS
City/State/Country
Oslo, NO
Establishment Address
Gaustadalleen 21, Oslo 0349, 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
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-08-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-08-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-08-03
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 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
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 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
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-07-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-07-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-07-27
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
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 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
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
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 2020-09-21
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 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

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
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30
K092915 Cedara Software Corp. CEDARA WEBACCESS, MODEL: 2.4 2010-06-23
K961871 Siemens Medical Solutions USA, Inc. FLOUROSPOT T.O.P. 1996-07-31
K122260 Aycan Digitalsysteme GmbH AYCAN MOBILE 2012-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007 AGFA Corp. 2
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

Registration Number Establishment Name Location
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3007120336 GE Healthcare Magyarorszag Kft. Budapest, HU
3036758981 TAEYOUNG SOFT Gwacheon-si Gyeonggi, KR
3010956703 Visual Medica Ciudad Autonoma Buenos Aires Buenos Aires, Ciudad Autonoma de, AR
3030088963 REBRAIN PESSAC Gironde, FR
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032807464. Last updated year: 2026. Please use registration number 3032807464 when referencing this establishment in official correspondence.
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