510(k) · Cleared
Recalled · Class II · 2018Vivid 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 Jun 12, 2017 as substantially equivalent to K150087 (Ge Vingmed Ultrasound AS, 2015) and 3 other predicates after an 84-day review. Its family tree reaches back 20 generations to 1995. 35 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 12, 2017
- Review
- 84 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 20 generations to K935595 (1995). 218 ancestors in all, the oldest K863700 (1987). 35 later devices descend from it, 3 citing it directly.
- Root · 20 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 16 generations between
- 3 generations backK141093 6VT-D Ultrasound TransducerGe Vingmed Ultrasound AS · 2014
- 2 generations backK142323 Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic…Ge Medical Systems Israel, Ltd. · 2014 · Recalled
- 1 generation backK150087 Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic…Ge Vingmed Ultrasound AS · 2015 · Recalled
- This deviceK170823 Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2017
- Descendant · cites it directly · 20 of its ownK173341 Vivid E80, Vivid E90, Vivid E95GE Medical Systems · 2017 · Recalled
- Descendant · 2 generations on · 13 of its ownK181685 Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- Descendant · cites it directly · 9 of its ownK181727 Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- Descendant · 2 generations on · 9 of its ownK182450 Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · Recalled
- Descendant · 3 generations on · 7 of its ownK200743 Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And · 2020
Show all 20 generations
- Root · 20 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 19 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 18 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 17 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 16 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 15 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 14 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 13 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 12 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 11 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 10 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 9 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 8 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 7 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 6 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 5 generations backK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
- 4 generations backK131514 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · Recalled
- 3 generations backK141093 6VT-D Ultrasound TransducerGe Vingmed Ultrasound AS · 2014
- 2 generations backK142323 Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic…Ge Medical Systems Israel, Ltd. · 2014 · Recalled
- 1 generation backK150087 Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic…Ge Vingmed Ultrasound AS · 2015 · Recalled
- This deviceK170823 Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2017
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems · 2017 · cites it directly20descendants
- K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · 2 generations on13descendants
- K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · cites it directly9descendants
- K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · 2 generations on9descendants
- K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And · 2020 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −19 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −18 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −17 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −16 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −15 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −14 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −13 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −12 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −11 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −10 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −9 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −8 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −7 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −6 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −5 | K123564 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2012 | 1 |
| −4 | K131514 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2013 | 2 |
| −3 | K141093 | 6VT-D Ultrasound Transducer | Ge Vingmed Ultrasound AS | 2014 | — |
| −2 | K142323 | Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System | Ge Medical Systems Israel, Ltd. | 2014 | 3 |
| −1 | K150087 | Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic… | Ge Vingmed Ultrasound AS | 2015 | 6 |
| 0 (this device) | K170823 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2017 | — |
| +1 | K173341 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems | 2017 | 3 |
| +2 | K181685 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | — |
| +1 | K181727 | Vivid iq | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | — |
| +2 | K182450 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | 2 |
| +3 | K200743 | Vivid E80/ Vivid E90/ Vivid E95 | Ge Medical Systems Ultrasound And | 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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 2 | 0 |
| 2022 | 7 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K150087 | Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Summary page 5…P P P P P P [7,8,9] Vascular Access (IV, PICC) P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New… | 2015 |
| * | K163077 | LOGIQ E9, LOGIQ E9 XDClear 2.0Summary page 5…P P [7,8,9] Vascular Access (IV, PICC) P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication Notes: [1] Abdominal includes renal, GYN/Pe… | 2016 |
| * | K142323 | Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemSummary page 5…y cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication Notes: [1] Abdominal includes renal, GYN/Pelvic [2] Small organ includes breast, testes, thyroid.… | 2014 |
| * | K150122 | Tomtec-Arena TTA2Summary page 23…vid E95 (K150087) Secondary Predicate LOGIQ E9 (K163077) Device(s): Vivid S60, Vivid S70 (K142323) TomTec Arena TTA2 (K150122) Device Description: Vivid E80 / Vivid E90 / Vivid E95 systems are Track 3 diagnostic ultraso… | 2015 |
What descends from it? (35)
See all 353 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 |
|---|---|---|---|---|
| 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 62 of the 218 ancestors have a recall of any class.
- Of its descendants, K173341 (GE Medical Systems, 2017) has gone furthest, with 20 descendants of its own.
- 3 other devices also cite its predicate K150087.
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. 2017, 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/K170823 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170823: Vivid E80, Vivid E90, Vivid E95.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170823
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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