510(k) · Cleared
Recalled · Class II · 2021ACUSON Sequoia Diagnostic 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 Jan 31, 2020 as substantially equivalent to K180067 (Siemens Medical Solutions USA, Inc., 2018) and 1 other predicate after a 66-day review. Its family tree reaches back 25 generations to 1995. 26 later devices descend from it. It has been recalled once.
- Decided
- Jan 31, 2020
- Review
- 66 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 25 generations to K935595 (1995). 211 ancestors in all, the oldest K863700 (1987). 26 later devices descend from it, 1 citing it directly.
- Root · 25 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 21 generations between
- 3 generations backK163635 ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group · 2017 · Recalled
- 2 generations backK172162 ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare · 2017
- 1 generation backK180067 ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018
- This deviceK193257 ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020
- Descendant · cites it directly · 25 of its ownK200707 ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020
- Descendant · 2 generations on · 24 of its ownK201462 ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 15 of its ownK210743 ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 7 of its ownK211859 ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2021 · Recalled
- Descendant · 4 generations on · 6 of its ownK221500 ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2022
Show all 25 generations
- Root · 25 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 24 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 23 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 22 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 21 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 20 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 19 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 18 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 17 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 16 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 15 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 14 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 13 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 12 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 11 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 10 generations backK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
- 9 generations backK123001 Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- 8 generations backK132804 Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · Recalled
- 7 generations backK140959 Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014
- 6 generations backK142876 ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- 5 generations backK152369 ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group · 2015
- 4 generations backK162243 ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016
- 3 generations backK163635 ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group · 2017 · Recalled
- 2 generations backK172162 ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare · 2017
- 1 generation backK180067 ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018
- This deviceK193257 ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020 · cites it directly25descendants
- K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020 · 2 generations on24descendants
- K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2021 · 3 generations on15descendants
- K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2021 · 3 generations on7descendants
- K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2022 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −24 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −23 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −22 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −21 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −20 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −19 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −18 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −17 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −16 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −15 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −14 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −13 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −12 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −11 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −10 | K121699 | Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −9 | K123001 | Acuson X700 Diagnstic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2012 | 2 |
| −8 | K132804 | Acuson S1000 / S2000 / S3000 | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013 | 3 |
| −7 | K140959 | Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −6 | K142876 | ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | 1 |
| −5 | K152369 | ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2015 | — |
| −4 | K162243 | ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2016 | — |
| −3 | K163635 | ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2017 | 1 |
| −2 | K172162 | ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems | Siemens Healthcare | 2017 | — |
| −1 | K180067 | ACUSON X800 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2018 | — |
| 0 (this device) | K193257 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +1 | K200707 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +2 | K201462 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| +3 | K210743 | ACUSON Redwood Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2021 | 3 |
| +3 | K211859 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2021 | 1 |
| +4 | K221500 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 3 | 0 |
| 1997 | 7 | 0 |
| 1998 | 4 | 0 |
| 1999 | 7 | 0 |
| 2000 | 8 | 0 |
| 2001 | 11 | 0 |
| 2002 | 13 | 0 |
| 2003 | 14 | 0 |
| 2004 | 18 | 0 |
| 2005 | 13 | 0 |
| 2006 | 9 | 0 |
| 2007 | 11 | 0 |
| 2008 | 9 | 0 |
| 2009 | 9 | 0 |
| 2010 | 8 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 6 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K180067 | ACUSON X800 Diagnostic Ultrasound SystemSummary page 4…P P P P P BMDC Superficial Other (specify) N = new indication; P = previously cleared by K180067 Note 1 For example: breast, testes, thyroid, penis, prostate, etc. (PLEASE DO NOT WRITE BELO… | 2018 |
| * | K172162 | ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSummary page 18…roprietary software, and is substantially equivalent to the company’s own products, the ACUSON X800 (K180067) which is primary predicated device and the ACUSON S family (K172162). The additional predicates are the indications for Neonatal Cephalic and 18H6, 10V4 transducers which are cleared under ACUSON S… | 2017 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200707 | ACUSON Sequoia Diagnostic Ultrasound System | 2020 | 25 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 4, 2021 | Class II | Z-1330-2021 | Software Design Change | The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD, which may influence patient management decisions… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 57 of the 211 ancestors have a recall of any class.
- Of its descendants, K200707 (Siemens Medical Solutions USA, Inc., 2020) has gone furthest, with 25 descendants of its own.
- 1 other device also cites its predicate K180067.
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. 2020, this device’s year, is highlighted.
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 ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Musculoskeletal and Peripheral Vascular applications.…
Read the full statement (108 words)
The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Musculoskeletal and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
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/K193257 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193257: ACUSON Sequoia Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193257
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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