510(k) · Cleared
Recalled · Class II · 2024Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Vingmed Ultrasound AS · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Mar 4, 2015 as substantially equivalent to K131514 (Ge Vingmed Ultrasound AS, 2013) and 2 other predicates after a 48-day review. Its family tree reaches back 19 generations to 1995. 73 later devices descend from it. It has been recalled 6 times.
- Decided
- Mar 4, 2015
- Review
- 48 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 19 generations to K935595 (1995). 150 ancestors in all, the oldest K863700 (1987). 73 later devices descend from it, 4 citing it directly.
- Root · 19 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 15 generations between
- 3 generations backK131514 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · Recalled
- 2 generations backK141093 6VT-D Ultrasound TransducerGe Vingmed Ultrasound AS · 2014
- 1 generation backK142323 Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic…Ge Medical Systems Israel, Ltd. · 2014 · Recalled
- This deviceK150087 Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic…Ge Vingmed Ultrasound AS · 2015
- Descendant · cites it directly · 46 of its ownK161706 Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L · 2016
- Descendant · cites it directly · 35 of its ownK170823 Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2017 · Recalled
- Descendant · 2 generations on · 28 of its ownK180599 VenueGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- Descendant · 2 generations on · 20 of its ownK173341 Vivid E80, Vivid E90, Vivid E95GE Medical Systems · 2017 · Recalled
- Descendant · cites it directly · 18 of its ownK172342 Voluson E6, Voluson E8, Voluson E10GE Healthcare · 2017
Show all 19 generations
- Root · 19 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 18 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 17 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 16 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 15 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 14 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 13 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 12 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 11 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 10 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 9 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 8 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 7 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 6 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 5 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 4 generations backK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
- 3 generations backK131514 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · Recalled
- 2 generations backK141093 6VT-D Ultrasound TransducerGe Vingmed Ultrasound AS · 2014
- 1 generation backK142323 Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic…Ge Medical Systems Israel, Ltd. · 2014 · Recalled
- This deviceK150087 Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic…Ge Vingmed Ultrasound AS · 2015
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
2016high 13 (2020) · low 1 (2016)2026
Most influential descendants
Showing 5 of 73 · See all- K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L · 2016 · cites it directly46descendants
- K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2017 · cites it directly35descendants
- K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · 2 generations on28descendants
- K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems · 2017 · 2 generations on20descendants
- K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare · 2017 · cites it directly18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −18 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −17 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −16 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −15 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −14 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −13 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −12 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −11 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −10 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −9 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −8 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −7 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −6 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −5 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −4 | K123564 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2012 | 1 |
| −3 | K131514 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2013 | 2 |
| −2 | K141093 | 6VT-D Ultrasound Transducer | Ge Vingmed Ultrasound AS | 2014 | — |
| −1 | K142323 | Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System | Ge Medical Systems Israel, Ltd. | 2014 | 3 |
| 0 (this device) | K150087 | Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic… | Ge Vingmed Ultrasound AS | 2015 | — |
| +1 | K161706 | Vivid iq | Ge Medical Systems Ultrasound and Primary Care Diagnostics L | 2016 | — |
| +1 | K170823 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2017 | 3 |
| +2 | K180599 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | — |
| +2 | K173341 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems | 2017 | 3 |
| +1 | K172342 | Voluson E6, Voluson E8, Voluson E10 | GE Healthcare | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 11 | 0 |
| 2003 | 12 | 0 |
| 2004 | 14 | 0 |
| 2005 | 10 | 0 |
| 2006 | 9 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 5 | 0 |
| 2020 | 13 | 0 |
| 2021 | 7 | 0 |
| 2022 | 12 | 0 |
| 2023 | 5 | 0 |
| 2024 | 6 | 0 |
| 2025 | 7 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K131514 | GE Vivid E9 Diagnostic Ultrasound Imaging SystemSummary page 5…Transrectal Transvaginal Transuretheral Intraoperative (specify) Intraoperative Neurological Intravascular Laparoscopic P = previously cleared by FDA on Vivid E9 (K131514) Notes: [1] Cardiac is Adult and Pediatric. [*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.… | 2013 |
| * | K142323 | Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemSummary page 14…srectal Transvaginal Transuretheral Intraoperative (specify) Intraoperative Neurological Intravascular Laparoscopic P = previously cleared by FDA on Vivid S60/S70 (K142323) Notes: [1] Abdominal includes Renal, GYN/Pelvic. [2] Small organ includes breast, testes, thyroid. [4] Other use… | 2014 |
| * | K142160 | Logiq E9 Diagnostic Ultrasound SystemSummary page 15…P P P P P P P Intraoperative Neurological Intravascular Laparoscopic P = previously cleared by FDA on Logiq E9 (K142160) Notes: [1] Abdominal includes Renal, GYN/Pelvic. [2] Small organ includes breast, testes, thyroid. [4] Other use… | 2014 |
What descends from it? (73)
See all 734 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 2, 2024 | Class II | Z-2316-2024 | Device Design | 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… |
| Mar 22, 2018 | Class II | Z-2986-2018 | Component design/selection | The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. |
| Mar 22, 2018 | Class II | Z-2987-2018 | Component design/selection | The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. |
| Mar 22, 2018 | Class II | Z-2988-2018 | Component design/selection | The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. |
| Mar 10, 2017 | Class II | Z-1780-2017 | Software design | GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue is limited to certain Vivid Ultrasound… |
| Mar 10, 2017 | Class II | Z-1779-2017 | Software design | GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue is limited to certain Vivid Ultrasound… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 49 of the 150 ancestors have a recall of any class.
- Of its descendants, K161706 (Ge Medical Systems Ultrasound and Primary Care Diagnostics L, 2016) has gone furthest, with 46 descendants of its own.
- 5 other devices also cite its predicate K131514.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2007high 64 (2017) · low 13 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
2007high 124 (2025) · low 18 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
2007high 16 (2007) · low 0 (2017)2026
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
2007high 610 (2025) · low 2 (2008)2025
MAUDE reports naming product code IYN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150087 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150087: Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150087
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026