510(k) · Cleared
ClearedAcuson
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 Dec 24, 2013 as substantially equivalent to K111674 (Siemens Medical Solutions USA, Inc., 2011) and 3 other predicates after a 244-day review. Its family tree reaches back 14 generations to 1995. 124 later devices descend from it.
- Decided
- Dec 24, 2013
- Review
- 244 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K935595 (1995). 80 ancestors in all, the oldest K891689 (1989). 124 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 10 generations between
- 3 generations backK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
- 2 generations backK102041 AixplorerSupersonic Imagine · 2010
- 1 generation backK121329 AixplorerSupersonic Imagine · 2012
- This deviceK131164 AcusonSiemens Medical Solutions USA, Inc. · 2013
- Descendant · cites it directly · 96 of its ownK151663 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- Descendant · 2 generations on · 90 of its ownK152962 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- Descendant · 2 generations on · 89 of its ownK153529 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · Recalled
- Descendant · 2 generations on · 65 of its ownK153408 HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- Descendant · 2 generations on · 64 of its ownK162094 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016
Show all 14 generations
- Root · 14 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 13 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 12 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 11 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 10 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 9 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 8 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 7 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 6 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 5 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 4 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 3 generations backK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
- 2 generations backK102041 AixplorerSupersonic Imagine · 2010
- 1 generation backK121329 AixplorerSupersonic Imagine · 2012
- This deviceK131164 AcusonSiemens Medical Solutions USA, Inc. · 2013
Showing 5 of 124 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 124 · See all- K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015 · cites it directly96descendants
- K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015 · 2 generations on90descendants
- K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · 2 generations on89descendants
- K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015 · 2 generations on65descendants
- K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · 2 generations on64descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −13 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −12 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −11 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −10 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −9 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −8 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −7 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −6 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −5 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −4 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −3 | K091970 | Aixplorer Ultrasound System | Supersonic Imagine | 2009 | — |
| −2 | K102041 | Aixplorer | Supersonic Imagine | 2010 | — |
| −1 | K121329 | Aixplorer | Supersonic Imagine | 2012 | — |
| 0 (this device) | K131164 | Acuson | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +1 | K151663 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| +2 | K152962 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| +2 | K153529 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | 1 |
| +2 | K153408 | HM70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| +2 | K162094 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 10 | 0 |
| 2018 | 11 | 0 |
| 2019 | 13 | 0 |
| 2020 | 8 | 0 |
| 2021 | 14 | 0 |
| 2022 | 15 | 0 |
| 2023 | 12 | 0 |
| 2024 | 11 | 0 |
| 2025 | 12 | 0 |
| 2026 | 9 | 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? (4)
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 |
|---|---|---|---|
| * | K111674 | AcusonSummary page 1…on S2000 and 33000 Ultrasound Systems are substantially equivalent to the company's own 32000 and 33000 Ultrasound Systems and Supersonic Imagine Shearwave Elastography (K1 11674. K122825, K1 12255, K121329) 4. Device Description: The S2000 and S3000 Ultrasound Systems are multi-purpose mobile, software con… | 2011 |
| * | K122825 | AcusonSummary page 1…nd 33000 Ultrasound Systems are substantially equivalent to the company's own 32000 and 33000 Ultrasound Systems and Supersonic Imagine Shearwave Elastography (K1 11674. K122825, K1 12255, K121329) 4. Device Description: The S2000 and S3000 Ultrasound Systems are multi-purpose mobile, software controlled d… | 2012 |
| * | K112255 | AixplorerSummary page 1…Ultrasound Systems are substantially equivalent to the company's own 32000 and 33000 Ultrasound Systems and Supersonic Imagine Shearwave Elastography (K1 11674. K122825, K1 12255, K121329) 4. Device Description: The S2000 and S3000 Ultrasound Systems are multi-purpose mobile, software controlled diagnostic… | 2012 |
| * | K121329 | AixplorerSummary page 1…Systems are substantially equivalent to the company's own 32000 and 33000 Ultrasound Systems and Supersonic Imagine Shearwave Elastography (K1 11674. K122825, K1 12255, K121329) 4. Device Description: The S2000 and S3000 Ultrasound Systems are multi-purpose mobile, software controlled diagnostic ultrasoun… | 2012 |
What descends from it? (124)
See all 1242 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 22 of the 80 ancestors have a recall of any class.
- Of its descendants, K151663 (Samsung Medison Co., Ltd., 2015) has gone furthest, with 96 descendants of its own.
- 5 other devices also cite its predicate K111674.
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. 2013, 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 S2000 and S3000 ultrasound imaging systems are intended for the following applications: Fetal. Abdominal. lntraoperative. Pediatric. Small Parts. Transcranial. OSIGYN. Cardiac. Pelvic, Neonatal/Adult Cephalic, Vascular. Musculoskeletal. Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal. abdominal. intraoperative. intratoperative neurological, pediatric small…
Read the full statement (234 words)
The S2000 and S3000 ultrasound imaging systems are intended for the following applications: Fetal. Abdominal. lntraoperative. Pediatric. Small Parts. Transcranial. OSIGYN. Cardiac. Pelvic, Neonatal/Adult Cephalic, Vascular. Musculoskeletal. Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures {fetal. abdominal. intraoperative. intratoperative neurological, pediatric small organ, neonatal cephalic. adult cephalic. cardiac. trans-esophageal. transrectal. transvaginal. peripheral vessel. musculo-skeletal (conventional). niusculo-skeletal (superficial) and neonatal cardiac) and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Arterial Neath Package (AHP) software provides the physician with the capabiity to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating withi patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography: Carotid Intima-Media Thickness Task Force. Endowsed by the Society for Vascular Imaging'.
The Acuson Acunav Ultrasound Catheter is intended for innr-cardiac 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131164: Acuson.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131164
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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