Data / Medical devices / Norway / GE Vingmed Ultrasound AS
GE Vingmed Ultrasound AS: FDA-registered device maker in Oslo, Norway, 28 510(k) clearances
GE Vingmed Ultrasound AS is registered with the FDA (registration 3032807464) in Oslo, Norway. It lists 6 device types. The FDA files 28 510(k) clearances under its listings, the newest dated September 16, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3032807464
- Address
- Gaustadalleen 21, Oslo, Norway, 0349
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Specification developer
- First device listed
- June 2, 2014
- Registered through
- 2027
- Brand names listed
- 10-D, 10T-D, 11L-D, 12S-D, 3Sc-RS, 4D ICE catheter, 4V-D, 4Vc-D and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 16, 2026 | K261623 | EchoPAC Software Only / EchoPAC Plug-in (v211) | QIH | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| July 16, 2025 | K251342 | EchoPAC Software Only / EchoPAC Plug-in | QIH | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| July 10, 2025 | K251169 | Vivid Pioneer | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| May 1, 2025 | K250087 | Vscan Air | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| August 15, 2023 | K231301 | Vscan Air | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| February 16, 2023 | K223832 | Vivid S60N, Vivid S70N | IYN | Substantially Equivalent | Ge Medical System Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| July 22, 2022 | K220940 | EchoPAC Software Only, EchoPAC Plug-in | QIH | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| July 22, 2022 | K220882 | Vivid E80, Vivid E90, Vivid E95 | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound And | accessdata.fda.gov |
| July 15, 2022 | K220619 | Vivid S60N, Vivid S70N | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 9, 2021 | K211216 | Vivid S60N / Vivid S70N | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| March 5, 2021 | K202658 | Vivid E80/ Vivid E90/ Vivid E95 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 20, 2020 | K202035 | Vscan Air | ITX | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| September 18, 2020 | K200852 | EchoPAC Software Only, EchoPAC Plug-In | LLZ | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| July 23, 2020 | K200743 | Vivid E80/ Vivid E90/ Vivid E95 | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound And | accessdata.fda.gov |
| July 16, 2020 | K200497 | Vivid S60N, Vivid S70N | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 25, 2018 | K181685 | Vivid E80, Vivid E90, Vivid E95 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 19, 2018 | K182450 | Vivid S60N, Vivid S70N | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 25, 2018 | K180995 | Vscan Extend | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 2, 2017 | K173341 | Vivid E80, Vivid E90, Vivid E95 | IYN | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| June 14, 2017 | K170878 | Vivid S60N, Vivid S70N | IYN | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| June 14, 2017 | K170847 | EchoPAC Software Only, EchoPAC Plug-in | LLZ | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 12, 2017 | K170823 | Vivid E80, Vivid E90, Vivid E95 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| August 31, 2016 | K161588 | Vscan Extend | IYN | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| March 4, 2015 | K150087 | Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System | IYN | Substantially Equivalent | Ge Vingmed Ultrasound AS | accessdata.fda.gov |
| March 2, 2015 | K150085 | GE EchoPAC | LLZ | Substantially Equivalent | Ge Vingmed Ultrasound AS | accessdata.fda.gov |
| October 10, 2014 | K142323 | Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Ge Medical Systems Israel , Ltd. | accessdata.fda.gov |
| May 16, 2014 | K140693 | VSCAN WITH DUAL PROBE | IYN | Substantially Equivalent | Ge Medical Sysyems Ultrasound & Primary Care Diagn | accessdata.fda.gov |
| May 15, 2014 | K141093 | 6VT-D ULTRASOUND TRANSDUCER | ITX | Substantially Equivalent | Ge Vingmed Ultrasound AS | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of System, Image Processing, Radiological
- All makers of Catheter, Ultrasound, Intravascular
- All makers of Automated Radiological Image Processing Software
Updated September 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.