510(k) · Cleared
Recalled · Class II · 2022GE Vivid I Diagnostic Ultrasound, GE Vivid Q Diagnostic Ultrasound
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Israel, Ultrasound, Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Aug 21, 2009 as substantially equivalent to K082374 (Ge Medical Systems Israel, Ultrasound, Ltd., 2008) after a 37-day review. Its family tree reaches back 5 generations to 2000. 285 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 21, 2009
- Review
- 37 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000695 (2000). 285 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK000695 GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler…Ge Medical Systems, Inc. · 2000
- 4 generations backK020789 GE Vivid 3 Expert; GE Vivid 3 ProGeneral Electric Co. · 2002
- 3 generations backK033139 GE Marlin UltrasoundGeneral Electric Co. · 2003 · Recalled
- 2 generations backK061525 GE Vivid - IGeneral Electric Co. · 2006 · Recalled
- 1 generation backK082374 Vivid I and Vivid QGe Medical Systems Israel, Ultrasound, Ltd. · 2008 · Recalled
- This deviceK092140 GE Vivid I Diagnostic Ultrasound, GE Vivid Q Diagnostic UltrasoundGe Medical Systems Israel, Ultrasound, Ltd. · 2009
- Descendant · cites it directly · 284 of its ownK102388 Vivid I Diagnostic Ultrasound SystemGe Medical System Israel, Ltd. · 2010 · Recalled
- Descendant · 2 generations on · 253 of its ownK120201 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2012 · Recalled
- Descendant · 3 generations on · 167 of its ownK131514 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · Recalled
- Descendant · 2 generations on · 110 of its ownK121062 Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound…Ge Medical System Israel, Ltd. · 2012 · Recalled
- Descendant · 4 generations on · 100 of its ownK152309 LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · Recalled
Showing 5 of 285 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 285 · See all- K102388Vivid I Diagnostic Ultrasound SystemGe Medical System Israel, Ltd. · 2010 · cites it directly284descendants
- K120201GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2012 · 2 generations on253descendants
- K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · 3 generations on167descendants
- K121062Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound SystemGe Medical System Israel, Ltd. · 2012 · 2 generations on110descendants
- K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · 4 generations on100descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000695 | GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler Imaging… | Ge Medical Systems, Inc. | 2000 | — |
| −4 | K020789 | GE Vivid 3 Expert; GE Vivid 3 Pro | General Electric Co. | 2002 | — |
| −3 | K033139 | GE Marlin Ultrasound | General Electric Co. | 2003 | 1 |
| −2 | K061525 | GE Vivid - I | General Electric Co. | 2006 | 1 |
| −1 | K082374 | Vivid I and Vivid Q | Ge Medical Systems Israel, Ultrasound, Ltd. | 2008 | 2 |
| 0 (this device) | K092140 | GE Vivid I Diagnostic Ultrasound, GE Vivid Q Diagnostic Ultrasound | Ge Medical Systems Israel, Ultrasound, Ltd. | 2009 | — |
| +1 | K102388 | Vivid I Diagnostic Ultrasound System | Ge Medical System Israel, Ltd. | 2010 | 2 |
| +2 | K120201 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2012 | 1 |
| +3 | K131514 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2013 | 2 |
| +2 | K121062 | Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound System | Ge Medical System Israel, Ltd. | 2012 | 1 |
| +4 | K152309 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 12 | 0 |
| 2016 | 10 | 0 |
| 2017 | 19 | 0 |
| 2018 | 23 | 0 |
| 2019 | 20 | 0 |
| 2020 | 29 | 0 |
| 2021 | 25 | 0 |
| 2022 | 29 | 0 |
| 2023 | 24 | 0 |
| 2024 | 33 | 0 |
| 2025 | 31 | 0 |
| 2026 | 22 | 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 |
|---|---|---|---|
| * | K082374 | Vivid I and Vivid QSummary page 1….1560, 90-IYO Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE Vivid i and Vivid q Diagnostic Ultrasound System K082374, currently in commercial distribution. 4. Device Description: The GE Vivid-i and Vivid-q is compact and po… | 2008 |
What descends from it? (285)
See all 2851 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102388 | Vivid I Diagnostic Ultrasound System | 2010 | 284 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 10, 2022 | Class II | Z-0756-2023 | Device Design | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. |
| Nov 10, 2022 | Class II | Z-0757-2023 | Device Design | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K102388 (Ge Medical System Israel, Ltd., 2010) has gone furthest, with 284 descendants of its own.
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. 2009, 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?
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; Intraoperative (abdominal, thoracic, and vascular), Intra-cardiac and Intra-luminal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092140: GE Vivid I Diagnostic Ultrasound, GE Vivid Q Diagnostic Ultrasound.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092140
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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