510(k) · Cleared
ClearedGE Vivid 7 BT04
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 2, 2004 as substantially equivalent to K003931 (Ge Medical Systems, Inc., 2001) and 1 other predicate after a 23-day review. Its family tree reaches back 2 generations to 2001. 2 of the 999 devices in its family, counting itself, have a Class I recall. 996 later devices descend from it.
- Decided
- Jul 2, 2004
- Review
- 23 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003931 (2001). 996 later devices descend from it, 5 citing it directly. 2 of the 999 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK003931 Vivid 7 with Sonopac, Model FB0008XXGe Medical Systems, Inc. · 2001
- 1 generation backK031663 GE Vivid 7, Model FC0003XXGeneral Electric Co. · 2003
- This deviceK041552 GE Vivid 7 BT04General Electric Co. · 2004
- Descendant · cites it directly · 979 of its ownK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- Descendant · 2 generations on · 972 of its ownK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- Descendant · 3 generations on · 838 of its ownK063085 Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 806 of its ownK052021 V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 802 of its ownK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
Showing 5 of 996 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 996 · See all- K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · cites it directly979descendants
- K052410Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 2 generations on972descendants
- K063085Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · 3 generations on838descendants
- K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · 2 generations on806descendants
- K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · 3 generations on802descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003931 | Vivid 7 with Sonopac, Model FB0008XX | Ge Medical Systems, Inc. | 2001 | — |
| −1 | K031663 | GE Vivid 7, Model FC0003XX | General Electric Co. | 2003 | — |
| 0 (this device) | K041552 | GE Vivid 7 BT04 | General Electric Co. | 2004 | — |
| +1 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| +2 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| +3 | K063085 | Modification to Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| +2 | K052021 | V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| +3 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 4 | 0 |
| 2006 | 5 | 0 |
| 2007 | 11 | 0 |
| 2008 | 15 | 0 |
| 2009 | 20 | 0 |
| 2010 | 20 | 0 |
| 2011 | 29 | 0 |
| 2012 | 41 | 0 |
| 2013 | 44 | 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 | 57 | 0 |
| 2024 | 65 | 0 |
| 2025 | 80 | 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? (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…, 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 (90-IYO/IYN/ITX) A device currently in commercial distribution. 4. Device Description: The GE Viv… | 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 (90-IYO/IYN/ITX) A device currently in commercial distribution. 4. Device Description: The GE Vivid 7 Dia… | 2003 |
What descends from it? (996)
See all 9965 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K051139 (Siemens Medical Solutions USA, Inc., 2005) has gone furthest, with 979 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: 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…
Read the full statement (312 words)
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:
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:
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:
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:
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:
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:
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:
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/K041552 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041552: GE Vivid 7 BT04.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041552
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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