510(k) · Cleared
ClearedVivid E80, Vivid E90, Vivid E95
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems Ultrasound and Primary Care Diagnostics · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Oct 25, 2018 as substantially equivalent to K173341 (GE Medical Systems, 2017) and 1 other predicate after a 121-day review. Its family tree reaches back 22 generations to 1995. 13 later devices descend from it.
- Decided
- Oct 25, 2018
- Review
- 121 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 22 generations to K935595 (1995). 220 ancestors in all, the oldest K863700 (1987). 13 later devices descend from it, 3 citing it directly.
- Root · 22 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 18 generations between
- 3 generations backK150087 Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic…Ge Vingmed Ultrasound AS · 2015 · Recalled
- 2 generations backK170823 Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2017 · Recalled
- 1 generation backK173341 Vivid E80, Vivid E90, Vivid E95GE Medical Systems · 2017 · Recalled
- This deviceK181685 Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- Descendant · cites it directly · 7 of its ownK200743 Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And · 2020
- Descendant · 2 generations on · 5 of its ownK202658 Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2021
- Descendant · cites it directly · 4 of its ownK201768 Voluson E10GE Healthcare · 2020
- Descendant · 2 generations on · 3 of its ownK220358 Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics · 2022
- Descendant · cites it directly · 3 of its ownK200852 EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020
Show all 22 generations
- Root · 22 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 21 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 20 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 19 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 18 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 17 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 16 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 15 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 14 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 13 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 12 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 11 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 10 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 9 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 8 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 7 generations backK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
- 6 generations backK131514 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · Recalled
- 5 generations backK141093 6VT-D Ultrasound TransducerGe Vingmed Ultrasound AS · 2014
- 4 generations backK142323 Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic…Ge Medical Systems Israel, Ltd. · 2014 · Recalled
- 3 generations backK150087 Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic…Ge Vingmed Ultrasound AS · 2015 · Recalled
- 2 generations backK170823 Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2017 · Recalled
- 1 generation backK173341 Vivid E80, Vivid E90, Vivid E95GE Medical Systems · 2017 · Recalled
- This deviceK181685 Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And · 2020 · cites it directly7descendants
- K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2021 · 2 generations on5descendants
- K201768Voluson E10GE Healthcare · 2020 · cites it directly4descendants
- K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics · 2022 · 2 generations on3descendants
- K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −21 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −20 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −19 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −18 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −17 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −16 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −15 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −14 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −13 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −12 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −11 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −10 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −9 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −8 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −7 | K123564 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2012 | 1 |
| −6 | K131514 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2013 | 2 |
| −5 | K141093 | 6VT-D Ultrasound Transducer | Ge Vingmed Ultrasound AS | 2014 | — |
| −4 | K142323 | Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System | Ge Medical Systems Israel, Ltd. | 2014 | 3 |
| −3 | K150087 | Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic… | Ge Vingmed Ultrasound AS | 2015 | 6 |
| −2 | K170823 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2017 | 3 |
| −1 | K173341 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems | 2017 | 3 |
| 0 (this device) | K181685 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | — |
| +1 | K200743 | Vivid E80/ Vivid E90/ Vivid E95 | Ge Medical Systems Ultrasound And | 2020 | — |
| +2 | K202658 | Vivid E80/ Vivid E90/ Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021 | — |
| +1 | K201768 | Voluson E10 | GE Healthcare | 2020 | — |
| +2 | K220358 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022 | — |
| +1 | K200852 | EchoPAC Software Only, EchoPAC Plug-In | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 9 | 0 |
| 1996 | 6 | 0 |
| 1997 | 10 | 0 |
| 1998 | 5 | 0 |
| 1999 | 12 | 0 |
| 2000 | 9 | 0 |
| 2001 | 9 | 0 |
| 2002 | 14 | 0 |
| 2003 | 13 | 0 |
| 2004 | 18 | 0 |
| 2005 | 10 | 0 |
| 2006 | 14 | 0 |
| 2007 | 10 | 0 |
| 2008 | 8 | 0 |
| 2009 | 6 | 0 |
| 2010 | 9 | 0 |
| 2011 | 7 | 0 |
| 2012 | 10 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K173341 | Vivid E80, Vivid E90, Vivid E95Summary page 4…those previously cleared with another GE Ultrasound system. There are no changes to the Indications for Use compared to the predicate Vivid E95 / Vivid E90 / Vivid E80 (K173341) The following Indication for Use forms are appended: System: Vivid E80 / Vivid E90 / Vivid E95 Transducer: C3-10-D Transducer:… | 2017 |
| * | K082185 | GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2Summary page 25…ransducer, 21 CFR 892.1570, 90-ITX Primary Predicate Device: Vivid E80, Vivid E90, Vivid E95 (K173341) Secondary Predicate Device(s): LOGIQ E9 (K082185) Device Description: Vivid E80 / Vivid E90 / Vivid E95 systems are Track 3 diagnostic ultras… | 2008 |
What descends from it? (13)
See all 133 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 9 companies; a new generation was cleared every 11 months on median.
- 64 of the 220 ancestors have a recall of any class.
- Of its descendants, K200743 (Ge Medical Systems Ultrasound And, 2020) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K173341.
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. 2018, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 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?
Vivid E80 / Vivid E90 / Vivid E95 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181685 · printed Nov 4, 2026
Cite this page
510(k) Report. “K181685: Vivid E80, Vivid E90, Vivid E95.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K181685
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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