510(k) · Cleared
Recalled · Class II · 2018GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX
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 Mar 31, 2006 as substantially equivalent to K003931 (Ge Medical Systems, Inc., 2001) and 3 other predicates after a 30-day review. Its family tree reaches back 4 generations to 2001. 689 later devices descend from it. It has been recalled once.
- Decided
- Mar 31, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K003931 (2001). 689 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK003931 Vivid 7 with Sonopac, Model FB0008XXGe Medical Systems, Inc. · 2001
- 3 generations backK031663 GE Vivid 7, Model FC0003XXGeneral Electric Co. · 2003
- 2 generations backK041552 GE Vivid 7 BT04General Electric Co. · 2004
- 1 generation backK051449 GE Vivid 7 with or Without SuffixGE Medical Systems · 2005
- This deviceK060542 GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XXGeneral Electric Co. · 2006
- 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
- Descendant · 3 generations on · 472 of its ownK110943 Logiq E9GE Healthcare · 2011 · Recalled
- Descendant · 4 generations on · 469 of its ownK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- Descendant · 3 generations on · 367 of its ownK111582 Logiq S8GE Healthcare · 2011 · Recalled
Showing 5 of 689 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 689 · See all- 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
- K110943Logiq E9GE Healthcare · 2011 · 3 generations on472descendants
- K113690GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · 4 generations on469descendants
- K111582Logiq S8GE Healthcare · 2011 · 3 generations on367descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003931 | Vivid 7 with Sonopac, Model FB0008XX | Ge Medical Systems, Inc. | 2001 | — |
| −3 | K031663 | GE Vivid 7, Model FC0003XX | General Electric Co. | 2003 | — |
| −2 | K041552 | GE Vivid 7 BT04 | General Electric Co. | 2004 | — |
| −1 | K051449 | GE Vivid 7 with or Without Suffix | GE Medical Systems | 2005 | — |
| 0 (this device) | K060542 | GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX | General Electric Co. | 2006 | — |
| +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 |
| +3 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| +4 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| +3 | K111582 | Logiq S8 | GE Healthcare | 2011 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 10 | 0 |
| 2011 | 14 | 0 |
| 2012 | 27 | 0 |
| 2013 | 26 | 0 |
| 2014 | 33 | 0 |
| 2015 | 38 | 0 |
| 2016 | 41 | 0 |
| 2017 | 61 | 0 |
| 2018 | 52 | 0 |
| 2019 | 37 | 0 |
| 2020 | 59 | 0 |
| 2021 | 41 | 0 |
| 2022 | 47 | 0 |
| 2023 | 47 | 0 |
| 2024 | 52 | 0 |
| 2025 | 59 | 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? (4)
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…, 21 CFR 892.1550, 90-IYN Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE Vivid 7 Diagnostic Ultrasound System K003931/K031663/K041552/K051449 (90-IYO/IYN/ITX) A device currently in commercial distribution. 4. Device Descript… | 2001 |
| * | K031663 | GE Vivid 7, Model FC0003XXSummary page 1…892.1550, 90-IYN Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE Vivid 7 Diagnostic Ultrasound System K003931/K031663/K041552/K051449 (90-IYO/IYN/ITX) A device currently in commercial distribution. 4. Device Description: The… | 2003 |
| * | K041552 | GE Vivid 7 BT04Summary page 1…0, 90-IYN Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE Vivid 7 Diagnostic Ultrasound System K003931/K031663/K041552/K051449 (90-IYO/IYN/ITX) A device currently in commercial distribution. 4. Device Description: The GE Vivi… | 2004 |
| * | K051449 | GE Vivid 7 with or Without SuffixSummary page 1…N Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE Vivid 7 Diagnostic Ultrasound System K003931/K031663/K041552/K051449 (90-IYO/IYN/ITX) A device currently in commercial distribution. 4. Device Description: The GE Vivid 7 Diag… | 2005 |
What descends from it? (689)
See all 6897 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081921 | GE Vivid E9 Ultrasound | 2008 | 579 |
| K072826 | Aplio Artida Diagnostic Ultrasound System | 2007 | 182 |
| K092691 | DC-7 Diagnostic Ultrasound System | 2009 | 176 |
| K072952 | GE Echopac | 2007 | 173 |
| K103677 | M7/M7T Diagnostic Ultrasound System | 2011 | 123 |
| K103583 | DC-7 Diagnostic Ultrasound System | 2010 | 123 |
| K110199 | DC-T6 Diagnostic Ultrasound System | 2011 | 117 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 22, 2018 | Class II | Z-2989-2018 | Component design/selection | The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K081921 (General Electric Co., 2008) has gone furthest, with 579 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/K060542 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060542: GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060542
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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