Data / Medical devices / Norway / Ge Vingmed Ultrasound A/S
Ge Vingmed Ultrasound A/S: FDA-registered device maker in HORTEN Vestfold, Norway, 81 510(k) clearances
Ge Vingmed Ultrasound A/S is registered with the FDA (registration 9610482) in HORTEN Vestfold, Norway. It lists 7 device types. The FDA files 81 510(k) clearances under its listings, the newest dated September 16, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9610482
- FEI number
- 3002808457
- Address
- Strandpromenaden 45, HORTEN Vestfold, Norway, 3191
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 14, 2011
- Registered through
- 2027
- Brand names listed
- 10-D, 10S-RS, 10T-D, 11L-D, 12L-RS, 12S-D, 12S-RS, 3CRF and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Twister, Brace Setting | ITO | 1 | Manufacturer | 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 |
| September 2, 2026 | K261313 | Vivid Explorer/Vivid Advanced/Vivid Focus | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| August 7, 2026 | K261668 | Venue Go | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | accessdata.fda.gov |
| July 30, 2026 | K261835 | LOGIQ Focus | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| May 26, 2026 | K260398 | LOGIQ e | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| March 24, 2026 | K260673 | LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| January 8, 2026 | K253370 | LOGIQ Totus | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| January 7, 2026 | K253366 | LOGIQ Fortis | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 29, 2025 | K251985 | LOGIQ E10 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 29, 2025 | K251963 | LOGIQ E10s | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| July 25, 2025 | K251322 | Venue; Venue Go; Venue Fit; Venue Sprint | IYN | 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 |
| February 11, 2025 | K243628 | Vivid T9/Vivid T8 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| February 11, 2025 | K243620 | Vivid iq | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 2, 2024 | K242005 | Versana Premier; Versana Premier Lotus; LOGIQ F | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 10, 2024 | K240111 | Venue | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 10, 2024 | K240053 | Venue Go | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 10, 2024 | K234106 | Venue Fit | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| December 7, 2023 | K232381 | LOGIQ Totus | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 7, 2023 | K231989 | LOGIQ E10s, LOGIQ Fortis | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound and Primary Care Diagnostic, | accessdata.fda.gov |
| November 7, 2023 | K231966 | LOGIQ E10 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 3, 2023 | K232186 | LOGIQ e | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound and Primary Care Diagnostic, | 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 18, 2022 | K221148 | Vivid iq | IYN | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| July 18, 2022 | K221147 | Vivid T8, Vivid T9 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | 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 27, 2022 | K220851 | Venue | IYN | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| June 27, 2022 | K220848 | Venue Fit | IYN | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| June 21, 2022 | K220800 | Venue Go | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| March 22, 2022 | K214039 | LOGIQ P10, LOGIQ P9, LOGIQ P8 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| September 10, 2021 | K211488 | LOGIQ E10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 27, 2021 | K211524 | LOGIQ E10s, LOGIQ Fortis | IYN | Substantially Equivalent | GE Healthcare | 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 |
| January 8, 2021 | K203114 | LOGIQ P10, LOGIQ P9, LOGIQ P8 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| December 29, 2020 | K203137 | Venue Fit | 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 |
| November 18, 2020 | K202233 | Venue Go | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 13, 2020 | K202132 | Venue | IYN | 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 |
| September 9, 2020 | K200851 | Vivid T8, Vivid T9 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| September 9, 2020 | K200708 | Vivid iq | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound And | 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 |
| April 1, 2020 | K200119 | LOGIQ E10s | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| August 29, 2019 | K192159 | Voluson E6, Voluson E8, Voluson E10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| January 28, 2019 | K183362 | Venue GO | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| December 6, 2018 | K181727 | Vivid iq | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 6, 2018 | K181934 | Vivid T8, Vivid T9 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 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 |
| September 20, 2018 | K181783 | LOGIQ P9; LOGIQ P7 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 25, 2018 | K180995 | Vscan Extend | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| May 2, 2018 | K180599 | Venue | 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 |
| April 11, 2017 | K170445 | LOGIQ S8 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| February 10, 2017 | K163596 | LOGIQ P9 and LOGIQ P7 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| November 17, 2016 | K163077 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | 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 |
| August 5, 2016 | K161706 | Vivid iq | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound and Primary Care Diagnostics L | accessdata.fda.gov |
| March 10, 2016 | K160078 | Vivid T8 | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound and Primary Care Diagnotics, L | accessdata.fda.gov |
| February 26, 2016 | K160182 | LOGIQ S7 Expert | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 29, 2015 | K152195 | LOGIQ S8 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 18, 2015 | K151028 | LOGIQ e | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | 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 |
| February 10, 2015 | K142472 | Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | GE Healthcare | 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 |
| September 21, 2012 | K122327 | VOLUSON E6/E8/E8EXPERT/E10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 21, 2012 | K121063 | VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Ge Medical System Israel , Ltd. | accessdata.fda.gov |
| February 8, 2011 | K101236 | VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 2, 2024 | 94772 | Class II | Ongoing | GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA | GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and demographics can be displayed on the ultrasound scanner screen rather than the intended patient selected by the user. | accessdata.fda.gov |
| May 30, 2023 | 92505 | Class II | Ongoing | GE Healthcare Vivid S60, ultrasound device | GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Automated Radiological Image Processing Software
- All makers of Twister, Brace Setting
- All makers of System, Image Processing, Radiological
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.