510(k) · Cleared
ClearedAcuson Sequoia Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Sep 22, 2005 as substantially equivalent to K051139 (Siemens Medical Solutions USA, Inc., 2005) after a 20-day review. Its family tree reaches back 6 generations to 1995. 2 of the 994 devices in its family, counting itself, have a Class I recall. 972 later devices descend from it.
- Decided
- Sep 22, 2005
- Review
- 20 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K935595 (1995). 21 ancestors in all, the oldest K921148 (1992). 972 later devices descend from it, 7 citing it directly. 2 of the 994 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 5 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 4 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 3 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 2 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 1 generation backK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- This deviceK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- Descendant · cites it directly · 838 of its ownK063085 Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 800 of its ownK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 3 generations on · 588 of its ownK093563 IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- Descendant · 4 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
Showing 5 of 972 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 972 · See all- K063085Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · cites it directly838descendants
- K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · 2 generations on800descendants
- K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · 3 generations on588descendants
- K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 3 generations on582descendants
- K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 4 generations on569descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −5 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −4 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −3 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −2 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −1 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| 0 (this device) | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| +1 | K063085 | Modification to Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| +2 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +3 | K093563 | IU22 Ultrasound System and Transducers | Philips Ultrasound, Inc. | 2010 | 2 |
| +3 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| +4 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 7 | 0 |
| 2008 | 13 | 0 |
| 2009 | 20 | 0 |
| 2010 | 17 | 0 |
| 2011 | 29 | 0 |
| 2012 | 35 | 0 |
| 2013 | 42 | 0 |
| 2014 | 50 | 0 |
| 2015 | 59 | 0 |
| 2016 | 59 | 0 |
| 2017 | 76 | 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? (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 |
|---|---|---|---|
| * | K051139 | Acuson Sequoia Diagnostic Ultrasound SystemSummary page 2…e, and is substantially equivalent to our current product that is already cleared for USA distribution under the following 5 10(k) PreMarket Notification number: * # K051139 (May 13, 2005) cleared as ACUSON Sequoia TM Diagnostic Ultrasound System. The Sequoia Diagnostic Ultrasound System has… | 2005 |
What descends from it? (972)
See all 9727 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063085 | Modification to Acuson Sequoia Ultrasound System | 2006 | 838 |
| K072000 | Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0 | 2007 | 203 |
| K072090 | Siemens Diagnostic Ultrasound Systems | 2007 | 189 |
| K063500 | DC-6 Diagnostic Ultrasound System | 2006 | 189 |
| K063761 | Acuson P10 Diagnostic Ultrasound System | 2007 | 135 |
| K103583 | DC-7 Diagnostic Ultrasound System | 2010 | 123 |
| K060992 | Syngo US Workplace | 2006 | 97 |
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 10 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K063085 (Siemens Medical Solutions USA, Inc., 2006) has gone furthest, with 838 descendants of its own.
- 4 other devices also cite its predicate K051139.
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?
Ultrasound imaging or fluid flow analysis of the human body as follows:
The AcuNavTM Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.
The AcuNaVTM Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K052410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052410: Acuson Sequoia Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052410
Report an extraction error
Are you the manufacturer?
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