510(k) · Cleared
ClearedGE Vivid 7, Model FC0003XX
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 Jun 9, 2003 as substantially equivalent to K003931 (Ge Medical Systems, Inc., 2001) after an 11-day review. Its family tree reaches back 1 generation to 2001. 2 of the 1,005 devices in its family, counting itself, have a Class I recall. 1,003 later devices descend from it.
- Decided
- Jun 9, 2003
- Review
- 11 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003931 (2001). 1,003 later devices descend from it, 6 citing it directly. 2 of the 1,005 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK003931 Vivid 7 with Sonopac, Model FB0008XXGe Medical Systems, Inc. · 2001
- This deviceK031663 GE Vivid 7, Model FC0003XXGeneral Electric Co. · 2003
- Descendant · cites it directly · 996 of its ownK041552 GE Vivid 7 BT04General Electric Co. · 2004
- Descendant · 2 generations on · 979 of its ownK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- Descendant · 3 generations on · 972 of its ownK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- Descendant · 4 generations on · 838 of its ownK063085 Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 806 of its ownK052021 V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · Recalled
Showing 5 of 1,003 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 1,003 · See all- K041552GE Vivid 7 BT04General Electric Co. · 2004 · cites it directly996descendants
- K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 2 generations on979descendants
- K052410Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 3 generations on972descendants
- K063085Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · 4 generations on838descendants
- K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · 3 generations on806descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003931 | Vivid 7 with Sonopac, Model FB0008XX | Ge Medical Systems, Inc. | 2001 | — |
| 0 (this device) | K031663 | GE Vivid 7, Model FC0003XX | General Electric Co. | 2003 | — |
| +1 | K041552 | GE Vivid 7 BT04 | General Electric Co. | 2004 | — |
| +2 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| +3 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| +4 | K063085 | Modification to Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| +3 | K052021 | V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 12 | 0 |
| 2008 | 15 | 0 |
| 2009 | 20 | 0 |
| 2010 | 20 | 0 |
| 2011 | 29 | 0 |
| 2012 | 41 | 0 |
| 2013 | 46 | 0 |
| 2014 | 50 | 0 |
| 2015 | 59 | 0 |
| 2016 | 59 | 0 |
| 2017 | 77 | 0 |
| 2018 | 68 | 0 |
| 2019 | 49 | 0 |
| 2020 | 75 | 0 |
| 2021 | 54 | 0 |
| 2022 | 59 | 0 |
| 2023 | 58 | 0 |
| 2024 | 65 | 0 |
| 2025 | 81 | 2 |
| 2026 | 55 | 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K003931 | Vivid 7 with Sonopac, Model FB0008XX | 2001 |
What descends from it? (1,003)
See all 1,0036 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041552 | GE Vivid 7 BT04 | 2004 | 996 |
| K060542 | GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX | 2006 | 689 |
| K081921 | GE Vivid E9 Ultrasound | 2008 | 579 |
| K131514 | GE Vivid E9 Diagnostic Ultrasound Imaging System | 2013 | 167 |
| K071503 | System, Tomography, Computed Emission | 2007 | 5 |
| K053043 | Encompass Software Package | 2005 | 0 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
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 (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031663 · printed Nov 3, 2026
Cite this page
510(k) Report. “K031663: GE Vivid 7, Model FC0003XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K031663
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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