510(k) · Cleared
Recalled · Class II · 2013GE Vivid E9 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 · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 19, 2012 as substantially equivalent to K101149 (Ge Vingmed Ultrasound AS, 2010) and 2 other predicates after an 87-day review. Its family tree reaches back 7 generations to 2001. 253 later devices descend from it. It has been recalled once.
- Decided
- Apr 19, 2012
- Review
- 87 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 7 generations to K003931 (2001). 16 ancestors in all, the oldest K000695 (2000). 253 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK003931 Vivid 7 with Sonopac, Model FB0008XXGe Medical Systems, Inc. · 2001
- 6 generations backK031663 GE Vivid 7, Model FC0003XXGeneral Electric Co. · 2003
- 5 generations backK041552 GE Vivid 7 BT04General Electric Co. · 2004
- 4 generations backK051449 GE Vivid 7 with or Without SuffixGE Medical Systems · 2005
- 3 generations backK060542 GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XXGeneral Electric Co. · 2006 · Recalled
- 2 generations backK081921 GE Vivid E9 UltrasoundGeneral Electric Co. · 2008
- 1 generation backK101149 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2010
- This deviceK120201 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2012
- Descendant · cites it directly · 167 of its ownK131514 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · Recalled
- Descendant · 2 generations on · 100 of its ownK152309 LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · Recalled
- Descendant · cites it directly · 96 of its ownK132341 DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2013
- Descendant · 2 generations on · 85 of its ownK141093 6VT-D Ultrasound TransducerGe Vingmed Ultrasound AS · 2014
- Descendant · 2 generations on · 84 of its ownK142323 Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic…Ge Medical Systems Israel, Ltd. · 2014 · Recalled
Showing 5 of 253 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 253 · See all- K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · cites it directly167descendants
- K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · 2 generations on100descendants
- K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2013 · cites it directly96descendants
- K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS · 2014 · 2 generations on85descendants
- K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd. · 2014 · 2 generations on84descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003931 | Vivid 7 with Sonopac, Model FB0008XX | Ge Medical Systems, Inc. | 2001 | — |
| −6 | K031663 | GE Vivid 7, Model FC0003XX | General Electric Co. | 2003 | — |
| −5 | K041552 | GE Vivid 7 BT04 | General Electric Co. | 2004 | — |
| −4 | K051449 | GE Vivid 7 with or Without Suffix | GE Medical Systems | 2005 | — |
| −3 | K060542 | GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX | General Electric Co. | 2006 | 1 |
| −2 | K081921 | GE Vivid E9 Ultrasound | General Electric Co. | 2008 | — |
| −1 | K101149 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2010 | — |
| 0 (this device) | K120201 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2012 | — |
| +1 | K131514 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2013 | 2 |
| +2 | K152309 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2015 | 1 |
| +1 | K132341 | DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound Systems | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013 | — |
| +2 | 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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 12 | 0 |
| 2016 | 9 | 0 |
| 2017 | 18 | 0 |
| 2018 | 22 | 0 |
| 2019 | 19 | 0 |
| 2020 | 27 | 0 |
| 2021 | 23 | 0 |
| 2022 | 25 | 0 |
| 2023 | 20 | 0 |
| 2024 | 28 | 0 |
| 2025 | 26 | 0 |
| 2026 | 19 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K101149 | GE Vivid E9 Diagnostic Ultrasound Imaging SystemSummary page 1…ic Pulsed Echo Imaging System, 2ICFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Predicate Device(s): K101 149 Vivid E9 Diagnostic Ultrasound System K102388 Vivid i / Vivid q Diagnostic Ultrasound System… | 2010 |
| * | K102388 | Vivid I Diagnostic Ultrasound SystemSummary page 1…Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Predicate Device(s): K101 149 Vivid E9 Diagnostic Ultrasound System K102388 Vivid i / Vivid q Diagnostic Ultrasound System K08 1921 6Tc Transducer (Vivid E9) Device Des… | 2010 |
| * | K081921 | GE Vivid E9 UltrasoundSummary page 1…e(s): K101 149 Vivid E9 Diagnostic Ultrasound System K102388 Vivid i / Vivid q Diagnostic Ultrasound System K08 1921 6Tc Transducer (Vivid E9) Device Description: GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is… | 2008 |
What descends from it? (253)
See all 2532 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 |
|---|---|---|---|---|
| Oct 11, 2013 | Class II | Z-0373-2014 | Component change control | GE became aware of a potential safety issue due to a system slow down and system lock up associated with the software of Vivid E9 ultrasound system. During a critical procedure the Vivid E9 Scanner may gradually become unresponsive and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 8 of the 16 ancestors have a recall of any class.
- Of its descendants, K131514 (Ge Vingmed Ultrasound AS, 2013) has gone furthest, with 167 descendants of its own.
- 3 other devices also cite its predicate K101149.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
GE Vivid E9 ultrasound system 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; 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; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120201: GE Vivid E9 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/K120201
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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