510(k) · Cleared
Recalled · 2009Modification to Acuson 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. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Nov 14, 2006 as substantially equivalent to K052410 (Siemens Medical Solutions USA, Inc., 2005) after a 35-day review. Its family tree reaches back 7 generations to 1995. 2 of the 861 devices in its family, counting itself, have a Class I recall. 838 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 14, 2006
- Review
- 35 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 7 generations to K935595 (1995). 22 ancestors in all, the oldest K921148 (1992). 838 later devices descend from it, 8 citing it directly. 2 of the 861 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 6 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 5 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 4 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 3 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 2 generations backK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 1 generation backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- This deviceK063085 Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- Descendant · cites it directly · 800 of its ownK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 2 generations on · 588 of its ownK093563 IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- Descendant · 3 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- Descendant · 2 generations on · 528 of its ownK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
Showing 5 of 838 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 838 · See all- K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · cites it directly800descendants
- K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · 2 generations on588descendants
- K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 2 generations on582descendants
- K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 3 generations on569descendants
- K091970Aixplorer Ultrasound SystemSupersonic Imagine · 2009 · 2 generations on528descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −6 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −5 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −4 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −3 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −2 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −1 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| 0 (this device) | K063085 | Modification to Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +1 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +2 | K093563 | IU22 Ultrasound System and Transducers | Philips Ultrasound, Inc. | 2010 | 2 |
| +2 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| +3 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| +2 | K091970 | Aixplorer Ultrasound System | Supersonic Imagine | 2009 | — |
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 |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 9 | 0 |
| 2010 | 16 | 0 |
| 2011 | 23 | 0 |
| 2012 | 29 | 0 |
| 2013 | 36 | 0 |
| 2014 | 46 | 0 |
| 2015 | 52 | 0 |
| 2016 | 58 | 0 |
| 2017 | 73 | 0 |
| 2018 | 64 | 0 |
| 2019 | 46 | 0 |
| 2020 | 64 | 0 |
| 2021 | 49 | 0 |
| 2022 | 52 | 0 |
| 2023 | 50 | 0 |
| 2024 | 54 | 0 |
| 2025 | 66 | 2 |
| 2026 | 46 | 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K052410 | Acuson Sequoia Ultrasound SystemSummary page 1…ostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product the Siemens Acuson Sequoia ultrasound system (K052410). B. Device Description: The Siemens Acuson Sequoia has been designed to meet the following product safety standa… | 2005 |
| † | K051139 | Acuson Sequoia Diagnostic Ultrasound System | 2005 |
| † | K041319 | Sequoia Diagnostic Ultrasound System | 2004 |
| † | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | 2003 |
| † | K022567 | Sequoia Signature II Diagnostic Ultrasound System | 2002 |
| † | K002807 | 3D Organ Assessment W/ Magnetic Position Sensing | 2000 |
| † | K992631 | Acunav Diagnostic Ultrasound Catheter | 1999 |
| † | K992580 | Fetal Assessment Cap | 1999 |
| † | K973767 | Harmonic Imaging with Contrast | 1997 |
| † | K935595 | Acuson Model 3001 | 1995 |
| † | K052021 | V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer | 2005 |
| † | K033650 | Acunav 90/10 Diagnostic Ultrasound Catheter | 2004 |
| † | K033196 | Sonoline Antares with Clarify VE | 2003 |
| † | K042593 | Acuson Acunav 8F Ultrasound Catheter | 2004 |
What descends from it? (838)
See all 8388 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072786 | Acuson S2000 Ultrasound System | 2007 | 800 |
| K090276 | Acuson X300 Diagnostic Ultrasound System | 2009 | 277 |
| K072365 | Sequoia Plus Diagnostic Ultrasound System | 2007 | 233 |
| K111674 | Acuson | 2011 | 223 |
| K121138 | Acuson S3000 Diagnostic Ultrasound System | 2012 | 198 |
| K112596 | Acuson S2000 Diagnostic Ultrasound System | 2011 | 192 |
| K113647 | DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound System | 2011 | 116 |
| K102017 | SC2000 Diagnostic Ultrasound System | 2010 | 104 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 21, 2009 | Not classified | Z-1961-2011 | Software design | Overheating. A software bug may cause the transducer to overheat when used with certain transducer models. The transducer can become noticeably hot within a few minutes, which may cause patient discomfort or burns. |
| Jun 6, 2008 | Not classified | Z-2230-2008 | Process control | The product assembly can cause a failure of the transducer which results in a double and/or overlapped image which may ultimately result in misleading or false information, inability to accurately diagnose, incorrect… |
| Sep 25, 2007 | Not classified | Z-0661-2008 | Software design | Measurement Error affecting all Sequoia systems using the PAL video standard configuration and have a perspective PC installed: 1) The Sequoia" system is operating at a software revision below 8.0. 2) The Sequoia" system is configured to… |
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 11 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K072786 (Siemens Medical Solutions USA, Inc., 2007) has gone furthest, with 800 descendants of its own.
- 6 other devices also cite its predicate K052410.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The Sequoia ultrasound imaging system is intended for use in the following applications:
General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Transesophageal, Transrectal, Transvaginal, Peripheral Vessels, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance document.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063085 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063085: Modification to 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/K063085
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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