510(k) · Cleared
ClearedAcuson S2000 and S3000 Diagnostic Ultrasound Systems
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 6, 2013 as substantially equivalent to K111674 (Siemens Medical Solutions USA, Inc., 2011) and 3 other predicates after an 80-day review. Its family tree reaches back 14 generations to 1995. 177 later devices descend from it.
- Decided
- Jun 6, 2013
- Review
- 80 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). 177 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 10 generations between
- 3 generations backK081148 Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008 · Recalled
- 2 generations backK111674 AcusonSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 1 generation backK121138 Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution · 2012
- This deviceK130739 Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2013
- Descendant · cites it directly · 102 of its ownK133329 Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- Descendant · 2 generations on · 101 of its ownK141620 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- Descendant · cites it directly · 99 of its ownK143089 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- Descendant · 2 generations on · 98 of its ownK143264 H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- Descendant · 2 generations on · 97 of its ownK150478 A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
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 backK081148 Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008 · Recalled
- 2 generations backK111674 AcusonSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 1 generation backK121138 Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution · 2012
- This deviceK130739 Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2013
Showing 5 of 177 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 177 · See all- K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013 · cites it directly102descendants
- K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 2 generations on101descendants
- K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · cites it directly99descendants
- K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 2 generations on98descendants
- K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015 · 2 generations on97descendants
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 | K081148 | Siemens Acuson 2000 Ultrasound System with Abvs Transducer | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008 | 3 |
| −2 | K111674 | Acuson | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −1 | K121138 | Acuson S3000 Diagnostic Ultrasound System | Siemens Medical Solution | 2012 | — |
| 0 (this device) | K130739 | Acuson S2000 and S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +1 | K133329 | Ugeo WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| +2 | K141620 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| +1 | K143089 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| +2 | K143264 | H60 V2.00 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| +2 | K150478 | A35 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
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 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 7 | 0 |
| 2015 | 8 | 0 |
| 2016 | 10 | 0 |
| 2017 | 16 | 0 |
| 2018 | 16 | 0 |
| 2019 | 16 | 0 |
| 2020 | 14 | 0 |
| 2021 | 18 | 0 |
| 2022 | 19 | 0 |
| 2023 | 14 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 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…n S2000 and S3000 Ultrasound Systems are substantially equivalent to the company’'s own S2000 and S3000 Ultrasound Systems and Supersonic Imagine Shearwave Elastography (K111674, K121138, K112255, K121329) 4. Device Description: The S2000 and S3000 Ultrasound Systems are multi-purpose mobile, software co… | 2011 |
| * | K121138 | Acuson S3000 Diagnostic Ultrasound SystemSummary page 1…nd S3000 Ultrasound Systems are substantially equivalent to the company’'s own S2000 and S3000 Ultrasound Systems and Supersonic Imagine Shearwave Elastography (K111674, K121138, K112255, K121329) 4. Device Description: The S2000 and S3000 Ultrasound Systems are multi-purpose mobile, software controlled… | 2012 |
| * | K112255 | AixplorerSummary page 1…Ultrasound Systems are substantially equivalent to the company’'s own S2000 and S3000 Ultrasound Systems and Supersonic Imagine Shearwave Elastography (K111674, K121138, K112255, K121329) 4. Device Description: The S2000 and S3000 Ultrasound Systems are multi-purpose mobile, software controlled diagnosti… | 2012 |
| * | K121329 | AixplorerSummary page 1…d Systems are substantially equivalent to the company’'s own S2000 and S3000 Ultrasound Systems and Supersonic Imagine Shearwave Elastography (K111674, K121138, K112255, K121329) 4. Device Description: The S2000 and S3000 Ultrasound Systems are multi-purpose mobile, software controlled diagnostic ultraso… | 2012 |
What descends from it? (177)
See all 1773 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 11 months on median.
- 22 of the 80 ancestors have a recall of any class.
- Of its descendants, K133329 (Samsung Medison Co., Ltd., 2013) has gone furthest, with 102 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, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, 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, intraoperative neurological, pediatric, small…
Read the full statement (253 words)
The S2000 and S3000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, 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, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-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 Health Package (AHP) software provides the physician with the capability 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 with 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, Endorsed by the Society for Vascular Imaging".
The Acuson Acunav 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 of adult and pediatric patients.
Virtual Touch Imaging and eSie Touch Elastography provide qualitative visualization of relative stiffness between tissues with different elastic properties.
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/K130739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130739: Acuson S2000 and S3000 Diagnostic Ultrasound Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130739
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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