510(k) · Cleared
Recalled · Class II · 2022Vivid I Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical System Israel, Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Nov 4, 2010 as substantially equivalent to K092140 (Ge Medical Systems Israel, Ultrasound, Ltd., 2009) and 1 other predicate after a 73-day review. Its family tree reaches back 6 generations to 2000. 284 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 4, 2010
- Review
- 73 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 6 generations to K000695 (2000). 8 ancestors in all. 284 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK000695 GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler…Ge Medical Systems, Inc. · 2000
- 5 generations backK020789 GE Vivid 3 Expert; GE Vivid 3 ProGeneral Electric Co. · 2002
- 4 generations backK033139 GE Marlin UltrasoundGeneral Electric Co. · 2003 · Recalled
- 3 generations backK061525 GE Vivid - IGeneral Electric Co. · 2006 · Recalled
- 2 generations backK082374 Vivid I and Vivid QGe Medical Systems Israel, Ultrasound, Ltd. · 2008 · Recalled
- 1 generation backK092140 GE Vivid I Diagnostic Ultrasound, GE Vivid Q Diagnostic UltrasoundGe Medical Systems Israel, Ultrasound, Ltd. · 2009 · Recalled
- This deviceK102388 Vivid I Diagnostic Ultrasound SystemGe Medical System Israel, Ltd. · 2010
- Descendant · cites it directly · 253 of its ownK120201 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2012 · Recalled
- Descendant · 2 generations on · 167 of its ownK131514 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · Recalled
- Descendant · cites it directly · 110 of its ownK121062 Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound…Ge Medical System Israel, Ltd. · 2012 · Recalled
- Descendant · 3 generations on · 100 of its ownK152309 LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · Recalled
- Descendant · 2 generations on · 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
Showing 5 of 284 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 284 · See all- K120201GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2012 · cites it directly253descendants
- K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · 2 generations on167descendants
- K121062Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound SystemGe Medical System Israel, Ltd. · 2012 · cites it directly110descendants
- K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · 3 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 · 2 generations on96descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000695 | GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler Imaging… | Ge Medical Systems, Inc. | 2000 | — |
| −5 | K020789 | GE Vivid 3 Expert; GE Vivid 3 Pro | General Electric Co. | 2002 | — |
| −4 | K033139 | GE Marlin Ultrasound | General Electric Co. | 2003 | 1 |
| −3 | K061525 | GE Vivid - I | General Electric Co. | 2006 | 1 |
| −2 | K082374 | Vivid I and Vivid Q | Ge Medical Systems Israel, Ultrasound, Ltd. | 2008 | 2 |
| −1 | K092140 | GE Vivid I Diagnostic Ultrasound, GE Vivid Q Diagnostic Ultrasound | Ge Medical Systems Israel, Ultrasound, Ltd. | 2009 | 2 |
| 0 (this device) | K102388 | Vivid I Diagnostic Ultrasound System | Ge Medical System Israel, Ltd. | 2010 | — |
| +1 | K120201 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2012 | 1 |
| +2 | K131514 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2013 | 2 |
| +1 | K121062 | Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound System | Ge Medical System Israel, Ltd. | 2012 | 1 |
| +3 | K152309 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2015 | 1 |
| +2 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K092140 | GE Vivid I Diagnostic Ultrasound, GE Vivid Q Diagnostic UltrasoundSummary page 2…YO Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX Predicate Device(s): Vivid i and Vivid q Diagnostic Ultrasound Systems K092 140 and Vivid S5 and Vivid S6 Diagnostic Ultrasound Systems K092079, curr… | 2009 |
| * | K092079 | Modification to GE Vivid S5 and S6 Diagnostic UltrasoundSummary page 2…Predicate Device(s): Vivid i and Vivid q Diagnostic Ultrasound Systems K092 140 and Vivid S5 and Vivid S6 Diagnostic Ultrasound Systems K092079, currently in commercial distribution. Device Description: The Vivid-i and Vivid-q are comp… | 2009 |
What descends from it? (284)
See all 2843 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 |
|---|---|---|---|---|
| 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 10 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 8 ancestors have a recall of any class.
- Of its descendants, K120201 (Ge Vingmed Ultrasound AS, 2012) has gone furthest, with 253 descendants of its own.
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. 2010, 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?
The current modifications do not change the indications for use. As previously reported and cleared, the Vivid i/q ultrasound systems are intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Abdominal/GYN; Urology; Fetal/OB; Small Organ (breast, testes, thyroid); Pediatric; Neonatal & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculo-skeletal (conventional & superficial); Transesophageal; Intraoperative (abdominal, thoracic and PV); Transvaginal and Transrectal, Intra-cardiac and intra-luminal applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102388: Vivid I Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102388
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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