510(k) · Cleared
ClearedGE Vivid 7 with or Without Suffix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jun 16, 2005 as substantially equivalent to K003931 (Ge Medical Systems, Inc., 2001) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 2001. 704 later devices descend from it.
- Decided
- Jun 16, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003931 (2001). 704 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK003931 Vivid 7 with Sonopac, Model FB0008XXGe Medical Systems, Inc. · 2001
- 2 generations backK031663 GE Vivid 7, Model FC0003XXGeneral Electric Co. · 2003
- 1 generation backK041552 GE Vivid 7 BT04General Electric Co. · 2004
- This deviceK051449 GE Vivid 7 with or Without SuffixGE Medical Systems · 2005
- Descendant · cites it directly · 689 of its ownK060542 GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XXGeneral Electric Co. · 2006 · Recalled
- Descendant · cites it directly · 583 of its ownK080223 Zura Tee SystemImacor, LLC · 2008 · Recalled
- Descendant · 2 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- Descendant · cites it directly · 579 of its ownK081921 GE Vivid E9 UltrasoundGeneral Electric Co. · 2008
- Descendant · 2 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
Showing 5 of 704 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 704 · See all- K060542GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XXGeneral Electric Co. · 2006 · cites it directly689descendants
- K080223Zura Tee SystemImacor, LLC · 2008 · cites it directly583descendants
- K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 2 generations on582descendants
- K081921GE Vivid E9 UltrasoundGeneral Electric Co. · 2008 · cites it directly579descendants
- K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 2 generations on569descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003931 | Vivid 7 with Sonopac, Model FB0008XX | Ge Medical Systems, Inc. | 2001 | — |
| −2 | K031663 | GE Vivid 7, Model FC0003XX | General Electric Co. | 2003 | — |
| −1 | K041552 | GE Vivid 7 BT04 | General Electric Co. | 2004 | — |
| 0 (this device) | K051449 | GE Vivid 7 with or Without Suffix | GE Medical Systems | 2005 | — |
| +1 | K060542 | GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX | General Electric Co. | 2006 | 1 |
| +1 | K080223 | Zura Tee System | Imacor, LLC | 2008 | 1 |
| +2 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| +1 | K081921 | GE Vivid E9 Ultrasound | General Electric Co. | 2008 | — |
| +2 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 12 | 0 |
| 2011 | 15 | 0 |
| 2012 | 28 | 0 |
| 2013 | 26 | 0 |
| 2014 | 35 | 0 |
| 2015 | 38 | 0 |
| 2016 | 41 | 0 |
| 2017 | 62 | 0 |
| 2018 | 52 | 0 |
| 2019 | 37 | 0 |
| 2020 | 60 | 0 |
| 2021 | 41 | 0 |
| 2022 | 48 | 0 |
| 2023 | 47 | 0 |
| 2024 | 52 | 0 |
| 2025 | 60 | 0 |
| 2026 | 37 | 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 |
|---|---|---|---|
| * | K003931 | Vivid 7 with Sonopac, Model FB0008XXSummary page 1…(90-IYO/IYN/ITX) 3. Marketed Device: GE Vivid 7 Diagnostic Ultrasound System K003931/K041552 A device currently in commercial distribution.… | 2001 |
| * | K041552 | GE Vivid 7 BT04Summary page 1…(90-IYO/IYN/ITX) 3. Marketed Device: GE Vivid 7 Diagnostic Ultrasound System K003931/K041552 A device currently in commercial distribution.… | 2004 |
What descends from it? (704)
See all 7043 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 4 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K060542 (General Electric Co., 2006) has gone furthest, with 689 descendants of its own.
- 4 other devices also cite its predicate K003931.
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?
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/K051449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051449: GE Vivid 7 with or Without Suffix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051449
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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