510(k) · Cleared
Recalled · Class II · 2022GE Vivid - I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jul 3, 2006 as substantially equivalent to K033139 (General Electric Co., 2003) after a 31-day review. Its family tree reaches back 3 generations to 2000. 349 later devices descend from it. It has been recalled once.
- Decided
- Jul 3, 2006
- Review
- 31 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000695 (2000). 349 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK000695 GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler…Ge Medical Systems, Inc. · 2000
- 2 generations backK020789 GE Vivid 3 Expert; GE Vivid 3 ProGeneral Electric Co. · 2002
- 1 generation backK033139 GE Marlin UltrasoundGeneral Electric Co. · 2003 · Recalled
- This deviceK061525 GE Vivid - IGeneral Electric Co. · 2006
- Descendant · cites it directly · 286 of its ownK082374 Vivid I and Vivid QGe Medical Systems Israel, Ultrasound, Ltd. · 2008 · Recalled
- Descendant · 2 generations on · 285 of its ownK092140 GE Vivid I Diagnostic Ultrasound, GE Vivid Q Diagnostic UltrasoundGe Medical Systems Israel, Ultrasound, Ltd. · 2009 · Recalled
- Descendant · 3 generations on · 284 of its ownK102388 Vivid I Diagnostic Ultrasound SystemGe Medical System Israel, Ltd. · 2010 · Recalled
- Descendant · 4 generations on · 253 of its ownK120201 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2012 · Recalled
- Descendant · 5 generations on · 167 of its ownK131514 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · Recalled
Showing 5 of 349 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 349 · See all- K082374Vivid I and Vivid QGe Medical Systems Israel, Ultrasound, Ltd. · 2008 · cites it directly286descendants
- K092140GE Vivid I Diagnostic Ultrasound, GE Vivid Q Diagnostic UltrasoundGe Medical Systems Israel, Ultrasound, Ltd. · 2009 · 2 generations on285descendants
- K102388Vivid I Diagnostic Ultrasound SystemGe Medical System Israel, Ltd. · 2010 · 3 generations on284descendants
- K120201GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2012 · 4 generations on253descendants
- K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · 5 generations on167descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000695 | GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler Imaging… | Ge Medical Systems, Inc. | 2000 | — |
| −2 | K020789 | GE Vivid 3 Expert; GE Vivid 3 Pro | General Electric Co. | 2002 | — |
| −1 | K033139 | GE Marlin Ultrasound | General Electric Co. | 2003 | 1 |
| 0 (this device) | K061525 | GE Vivid - I | General Electric Co. | 2006 | — |
| +1 | K082374 | Vivid I and Vivid Q | Ge Medical Systems Israel, Ultrasound, Ltd. | 2008 | 2 |
| +2 | K092140 | GE Vivid I Diagnostic Ultrasound, GE Vivid Q Diagnostic Ultrasound | Ge Medical Systems Israel, Ultrasound, Ltd. | 2009 | 2 |
| +3 | K102388 | Vivid I Diagnostic Ultrasound System | Ge Medical System Israel, Ltd. | 2010 | 2 |
| +4 | K120201 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2012 | 1 |
| +5 | K131514 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2013 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 17 | 0 |
| 2016 | 15 | 0 |
| 2017 | 27 | 0 |
| 2018 | 25 | 0 |
| 2019 | 22 | 0 |
| 2020 | 32 | 0 |
| 2021 | 27 | 0 |
| 2022 | 32 | 0 |
| 2023 | 25 | 0 |
| 2024 | 38 | 0 |
| 2025 | 42 | 0 |
| 2026 | 30 | 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? (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 |
|---|---|---|---|
| * | K033139 | GE Marlin UltrasoundSummary page 1…Imaging System, 21 CFR 892.1560, 90-IYC Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE Vivid-i Ultrasound System, K033139 currently in commercial distribution. 4. Device Description: The GE LOGIQ Twin is a compact and portable diagnostic ultrasound sy… | 2003 |
What descends from it? (349)
See all 3493 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K082374 (Ge Medical Systems Israel, Ultrasound, Ltd., 2008) has gone furthest, with 286 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.
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 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; and Intraoperative (abdominal, thoracic, and vascular).
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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/K061525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061525: GE Vivid - I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061525
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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