510(k) · Cleared
ClearedGE 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 Oct 13, 2010 as substantially equivalent to K081921 (General Electric Co., 2008) after a 173-day review. Its family tree reaches back 6 generations to 2001. 350 later devices descend from it.
- Decided
- Oct 13, 2010
- Review
- 173 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K003931 (2001). 350 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK003931 Vivid 7 with Sonopac, Model FB0008XXGe Medical Systems, Inc. · 2001
- 5 generations backK031663 GE Vivid 7, Model FC0003XXGeneral Electric Co. · 2003
- 4 generations backK041552 GE Vivid 7 BT04General Electric Co. · 2004
- 3 generations backK051449 GE Vivid 7 with or Without SuffixGE Medical Systems · 2005
- 2 generations backK060542 GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XXGeneral Electric Co. · 2006 · Recalled
- 1 generation backK081921 GE Vivid E9 UltrasoundGeneral Electric Co. · 2008
- This deviceK101149 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2010
- Descendant · cites it directly · 253 of its ownK120201 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2012 · Recalled
- Descendant · cites it directly · 219 of its ownK131527 Logiq S8GE Healthcare · 2013
- Descendant · cites it directly · 176 of its ownK121063 Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic…Ge Medical System Israel, Ltd. · 2012 · Recalled
- Descendant · 2 generations on · 167 of its ownK131514 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · Recalled
- Descendant · 2 generations on · 155 of its ownK133034 Logiq F SeriesGE Healthcare · 2014
Showing 5 of 350 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 350 · See all- K120201GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2012 · cites it directly253descendants
- K131527Logiq S8GE Healthcare · 2013 · cites it directly219descendants
- K121063Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound SystemGe Medical System Israel, Ltd. · 2012 · cites it directly176descendants
- K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · 2 generations on167descendants
- K133034Logiq F SeriesGE Healthcare · 2014 · 2 generations on155descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003931 | Vivid 7 with Sonopac, Model FB0008XX | Ge Medical Systems, Inc. | 2001 | — |
| −5 | K031663 | GE Vivid 7, Model FC0003XX | General Electric Co. | 2003 | — |
| −4 | K041552 | GE Vivid 7 BT04 | General Electric Co. | 2004 | — |
| −3 | K051449 | GE Vivid 7 with or Without Suffix | GE Medical Systems | 2005 | — |
| −2 | K060542 | GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX | General Electric Co. | 2006 | 1 |
| −1 | K081921 | GE Vivid E9 Ultrasound | General Electric Co. | 2008 | — |
| 0 (this device) | K101149 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2010 | — |
| +1 | K120201 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2012 | 1 |
| +1 | K131527 | Logiq S8 | GE Healthcare | 2013 | — |
| +1 | K121063 | Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound System | Ge Medical System Israel, Ltd. | 2012 | 2 |
| +2 | K131514 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2013 | 2 |
| +2 | K133034 | Logiq F Series | GE Healthcare | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 9 | 0 |
| 2015 | 16 | 0 |
| 2016 | 16 | 0 |
| 2017 | 25 | 0 |
| 2018 | 30 | 0 |
| 2019 | 27 | 0 |
| 2020 | 36 | 0 |
| 2021 | 29 | 0 |
| 2022 | 35 | 0 |
| 2023 | 27 | 0 |
| 2024 | 36 | 0 |
| 2025 | 32 | 0 |
| 2026 | 23 | 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? (1)
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 |
|---|---|---|---|
| * | K081921 | GE Vivid E9 UltrasoundSummary page 1…System, 21 CFR 892.1560, 90-IYO Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Devices: GE Vivid E9 Ultrasound System, K081921, and GE Logiq E9 Ultrasound System, K092271, currently in commercial distribution. 4. Device Desciription: The GE Vivid E9… | 2008 |
| † | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | 2009 |
What descends from it? (350)
See all 3504 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 9 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K120201 (Ge Vingmed Ultrasound AS, 2012) has gone furthest, with 253 descendants of its own.
- 3 other devices also cite its predicate K081921.
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. 2010, 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?
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/K101149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101149: 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/K101149
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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