Data / Medical devices / Austria / GE Healthcare Austria GmbH & Co OG
GE Healthcare Austria GmbH & Co OG: FDA-registered device maker in ZIPF Oberosterreich, Austria, 72 510(k) clearances
GE Healthcare Austria GmbH & Co OG is registered with the FDA (registration 8020021) in ZIPF Oberosterreich, Austria. It lists 6 device types. The FDA files 72 510(k) clearances under its listings, the newest dated October 2, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 8020021
- FEI number
- 3004377820
- Address
- Tiefenbach 15, ZIPF Oberosterreich, Austria, 4871
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Manufacturer, Specification developer
- First device listed
- September 1, 2010
- Registered through
- 2027
- Brand names listed
- 10-D, 10L, 11L-D, 12L, 12L-RS, 12S-D, 12S-RS, 3.5C and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 2, 2026 | K261933 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | accessdata.fda.gov |
| 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 |
| November 24, 2025 | K252328 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | 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 29, 2025 | K250543 | Voluson Performance 16; Voluson Performance 18 | 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 |
| December 20, 2024 | K242168 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | 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 |
| March 7, 2024 | K233692 | Voluson Signature 20, Voluson Signature 18 | 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 |
| October 30, 2023 | K231965 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | 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 |
| June 20, 2023 | K230346 | Voluson SWIFT; Voluson SWIFT+ | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC | accessdata.fda.gov |
| February 15, 2023 | K223407 | Versana Essential | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 6, 2022 | K220358 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| May 11, 2022 | K220446 | Versana Balance | 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 |
| February 17, 2022 | K213689 | Voluson P6, Voluson P8 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| January 13, 2022 | K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 10, 2021 | K211488 | LOGIQ E10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 10, 2021 | K210438 | Versana Premier | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| August 27, 2021 | K211524 | LOGIQ E10s, LOGIQ Fortis | IYN | Substantially Equivalent | GE Healthcare | 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 |
| November 20, 2020 | K202035 | Vscan Air | ITX | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 11, 2020 | K201828 | Voluson SWIFT, Voluson SWIFT+ | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| July 1, 2020 | K200138 | Versana Premier | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound And | accessdata.fda.gov |
| June 11, 2020 | K200998 | Versana Active | 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 |
| August 9, 2019 | K191792 | Versana Balance | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| December 21, 2018 | K182750 | 4D View | LLZ | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 21, 2018 | K182277 | Versana Premier | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 15, 2018 | K181985 | Voluson E6, Voluson E8, Voluson E10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 20, 2018 | K181783 | LOGIQ P9; LOGIQ P7 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 29, 2018 | K180535 | Voluson P6 and Voluson P8 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 13, 2018 | K180374 | Voluson S8/ Voluson S10/ Voluson S10 Expert | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 29, 2017 | K172342 | Voluson E6, Voluson E8, Voluson E10 | IYN | Substantially Equivalent | GE Healthcare | 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 |
| October 3, 2016 | K162269 | Voluson E6, Voluson E8, Voluson E10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 5, 2016 | K161224 | LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| May 5, 2016 | K161047 | LOGIQ P9 and LOGIQ P7 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| April 26, 2016 | K160162 | Voluson P6, Voluson P8 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 25, 2016 | K160277 | LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| February 26, 2016 | K160182 | LOGIQ S7 Expert | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| February 25, 2016 | K160184 | Voluson S6, Voluson S8, Voluson S10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| November 6, 2015 | K152567 | Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 29, 2015 | K152195 | LOGIQ S8 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| February 10, 2015 | K142472 | Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 24, 2013 | K131937 | VOLUSON I/E | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| May 16, 2013 | K131118 | 4D VIEW | LLZ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 21, 2012 | K122327 | VOLUSON E6/E8/E8EXPERT/E10 | IYN | Substantially Equivalent | GE Healthcare | 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 |
| October 5, 2010 | K101874 | GE LOGIQ P6/P6 PRO | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 31, 2010 | K101878 | GE LOGIQ P5 MODEL H44662LD | 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 |
|---|---|---|---|---|---|---|
| December 22, 2023 | 93727 | Class II | Ongoing | GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis | GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Products List) that can result in a double image artifact creating a ghost image with realistic features. An unrecognized artifact may lead to misdiagnosis. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Automated Radiological Image Processing Software
- All makers of System, Image Processing, Radiological
- All makers of Twister, Brace Setting
Updated October 2, 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.