510(k) · Cleared
ClearedACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE 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 Jun 16, 2026 as substantially equivalent to K251481 (Siemens Medical Solutions USA, Inc., 2025) after a 92-day review. Its family tree reaches back 35 generations to 1995.
- Decided
- Jun 16, 2026
- Review
- 92 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 35 generations to K935595 (1995). 258 ancestors in all, the oldest K863700 (1987). No later device cites it as a predicate yet.
- Root · 35 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 31 generations between
- 3 generations backK240704 ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select…Siemens Medical Solutions USA, Inc. · 2024
- 2 generations backK242523 ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select…Siemens Medical Solutions USA, Inc. · 2024
- 1 generation backK251481 ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select…Siemens Medical Solutions USA, Inc. · 2025
- This deviceK260844 ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select…Siemens Medical Solutions USA, Inc. · 2026
Show all 35 generations
- Root · 35 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 34 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 33 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 32 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 31 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 30 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 29 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 28 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 27 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 26 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 25 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 24 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 23 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 22 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 21 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 20 generations backK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
- 19 generations backK123001 Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- 18 generations backK132804 Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · Recalled
- 17 generations backK140959 Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014
- 16 generations backK142876 ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- 15 generations backK152369 ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group · 2015
- 14 generations backK162243 ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016
- 13 generations backK163635 ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group · 2017 · Recalled
- 12 generations backK172162 ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare · 2017
- 11 generations backK180067 ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018
- 10 generations backK193257 ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- 9 generations backK200707 ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020
- 8 generations backK201462 ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- 7 generations backK210743 ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2021 · Recalled
- 6 generations backK221500 ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2022
- 5 generations backK223735 ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select…Siemens Medical Solutions USA, Inc. · 2023
- 4 generations backK232145 ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select…Siemens Medical Solutions USA, Inc. · 2023
- 3 generations backK240704 ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select…Siemens Medical Solutions USA, Inc. · 2024
- 2 generations backK242523 ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select…Siemens Medical Solutions USA, Inc. · 2024
- 1 generation backK251481 ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select…Siemens Medical Solutions USA, Inc. · 2025
- This deviceK260844 ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select…Siemens Medical Solutions USA, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −35 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −34 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −33 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −32 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −31 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −30 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −29 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −28 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −27 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −26 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −25 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −24 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −23 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −22 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −21 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −20 | K121699 | Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −19 | K123001 | Acuson X700 Diagnstic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2012 | 2 |
| −18 | K132804 | Acuson S1000 / S2000 / S3000 | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013 | 3 |
| −17 | K140959 | Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −16 | K142876 | ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | 1 |
| −15 | K152369 | ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2015 | — |
| −14 | K162243 | ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2016 | — |
| −13 | K163635 | ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2017 | 1 |
| −12 | K172162 | ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems | Siemens Healthcare | 2017 | — |
| −11 | K180067 | ACUSON X800 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2018 | — |
| −10 | K193257 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| −9 | K200707 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | — |
| −8 | K201462 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| −7 | K210743 | ACUSON Redwood Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2021 | 3 |
| −6 | K221500 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2022 | — |
| −5 | K223735 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic… | Siemens Medical Solutions USA, Inc. | 2023 | — |
| −4 | K232145 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic… | Siemens Medical Solutions USA, Inc. | 2023 | — |
| −3 | K240704 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic… | Siemens Medical Solutions USA, Inc. | 2024 | — |
| −2 | K242523 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic… | Siemens Medical Solutions USA, Inc. | 2024 | — |
| −1 | K251481 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic… | Siemens Medical Solutions USA, Inc. | 2025 | — |
| 0 (this device) | K260844 | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic… | Siemens Medical Solutions USA, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 7 | 0 |
| 1996 | 4 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 8 | 0 |
| 2000 | 9 | 0 |
| 2001 | 11 | 0 |
| 2002 | 14 | 0 |
| 2003 | 16 | 0 |
| 2004 | 18 | 0 |
| 2005 | 14 | 0 |
| 2006 | 10 | 0 |
| 2007 | 12 | 0 |
| 2008 | 10 | 0 |
| 2009 | 11 | 0 |
| 2010 | 11 | 0 |
| 2011 | 3 | 0 |
| 2012 | 8 | 0 |
| 2013 | 7 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 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 |
|---|---|---|---|
| * | K251481 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Summary page 8…tional accessories, and are substantially equivalent to the company’s own ultrasound devices. Predicate device: ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE (K251481) Reference device: ACUSON SC2000 (K233613) 4. Device Description The ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE Dia… | 2025 |
| * | — | company’s own ultrasound devices Named without a submission number | |
| † | K233613 | ACUSON SC2000 Diagnostic Ultrasound System | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 9 companies; a new generation was cleared every 9 months on median.
- 71 of the 258 ancestors have a recall of any class.
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. 2026, 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 and Sequoia Select ultrasound imaging systems are 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 (such as breast, testes, thyroid, penis prostate), OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac…
Read the full statement (307 words)
The ACUSON Sequoia and Sequoia Select ultrasound imaging systems are 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 (such as breast, testes, thyroid, penis prostate), OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.
The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult and pediatric patients with hepatic steatosis.
The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal, adult cephalic, 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.
The ACUSON Origin and Origin ICE ultrasound imaging systems are 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, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Intracardiac, Vascular, Adult Cephalic, and Peripheral Vascular applications.
The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, cardiac, peripheral vessel, 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 as stated in the FDA summary.
https://510kreport.com/device/K260844 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260844: ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260844
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026