510(k) · Cleared
ClearedAcuson S3000 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solution · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on May 17, 2012 as substantially equivalent to K111674 (Siemens Medical Solutions USA, Inc., 2011) and 6 other predicates after a 34-day review. Its family tree reaches back 13 generations to 1995. 198 later devices descend from it.
- Decided
- May 17, 2012
- Review
- 34 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 13 generations to K935595 (1995). 64 ancestors in all, the oldest K891689 (1989). 198 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 9 generations between
- 3 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK081148 Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008 · Recalled
- 1 generation backK111674 AcusonSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- This deviceK121138 Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution · 2012
- Descendant · cites it directly · 177 of its ownK130739 Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2013
- Descendant · cites it directly · 116 of its ownK130881 Acuson S2000 and S3000Siemens Medical Solutions USA, Inc. · 2013
- Descendant · 2 generations on · 102 of its ownK133329 Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- Descendant · 3 generations on · 101 of its ownK141620 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- Descendant · 2 generations on · 99 of its ownK143089 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
Show all 13 generations
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 12 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 11 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 10 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 9 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 8 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 7 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 6 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 5 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 4 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 3 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK081148 Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008 · Recalled
- 1 generation backK111674 AcusonSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- This deviceK121138 Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution · 2012
Showing 5 of 198 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 198 · See all- K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2013 · cites it directly177descendants
- K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc. · 2013 · cites it directly116descendants
- K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013 · 2 generations on102descendants
- K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 3 generations on101descendants
- K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 2 generations on99descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −12 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −11 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −10 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −9 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −8 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −7 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −6 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −5 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −4 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −3 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −2 | K081148 | Siemens Acuson 2000 Ultrasound System with Abvs Transducer | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008 | 3 |
| −1 | K111674 | Acuson | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| 0 (this device) | K121138 | Acuson S3000 Diagnostic Ultrasound System | Siemens Medical Solution | 2012 | — |
| +1 | K130739 | Acuson S2000 and S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +1 | K130881 | Acuson S2000 and S3000 | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +2 | K133329 | Ugeo WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| +3 | K141620 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| +2 | K143089 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
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 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 8 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 4 | 0 |
| 2014 | 7 | 0 |
| 2015 | 10 | 0 |
| 2016 | 15 | 0 |
| 2017 | 17 | 0 |
| 2018 | 19 | 0 |
| 2019 | 17 | 0 |
| 2020 | 14 | 0 |
| 2021 | 19 | 0 |
| 2022 | 20 | 0 |
| 2023 | 15 | 0 |
| 2024 | 13 | 0 |
| 2025 | 18 | 0 |
| 2026 | 10 | 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? (9)
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…plitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D14D Imaging on a Flat Panel Display. It is substantially equivalent to our current S2000 product (K1 11674, K(093812, K090334, K(072786, K(081148), and Siemens V7M (K(063085), AcuNav 8F and AcuNav 1lOF (K(071234) transducers. These pred… | 2011 |
| * | K093812 | Acuson S2000 Diagnostic Ultrasound SystemSummary page 2…Faue/Caatn.Acuson Acsn S2000 S2000 520 co 502780 K093812 K090334 K(111674 Indications for Use: "Fetal 44 4… | 2010 |
| * | K090334 | Acuson S2000 Diagnostic Ultrasound SystemSummary page 1…, a combination of modes, or Harmonic Imaging and 3D14D Imaging on a Flat Panel Display. It is substantially equivalent to our current S2000 product (K1 11674, K(093812, K090334, K(072786, K(081148), and Siemens V7M (K(063085), AcuNav 8F and AcuNav 1lOF (K(071234) transducers. These predicates are legally… | 2009 |
| * | K072786 | Acuson S2000 Ultrasound SystemSummary page 4…n S30 00 32000 S2000 320I00 S2000 K072786 K093812 K090334 K111674 Tested to ISO Tested to ISO Tested to ISO Tes… | 2007 |
| * | K081148 | Siemens Acuson 2000 Ultrasound System with Abvs TransducerSummary page 8…N N N N Note 3,4,6, 10MC Neonatal Cardiac N = new indication; P peviously cleared by FDA K063085, K063803, K072786, K081148, K082142, K090334, K093812, K1 11674 Note 1 For example: breast; testes, thyroid, penis, prostate, etc. Not… | 2008 |
| * | K063085 | Modification to Acuson Sequoia Ultrasound SystemSummary page 8…pecify) N[N N N N N Note 3,4,6, 10MC Neonatal Cardiac N = new indication; P peviously cleared by FDA K063085, K063803, K072786, K081148, K082142, K090334, K093812, K1 11674 Note 1 For example: breast; testes, thyroid, penis, prostate,… | 2006 |
| * | K071234 | Acunav Diagnostic Ultrasound Catheter 8F and 10FSummary page 31…Other (Intra-Cardiac) p tp p P P P P P=Previously cleared by the FDA K99263 1, K033650, K042593, K071234, K<093812, Kl111874 Additional Comments: *Combinations include: B+M. B±PWD. B+CWD. B±Color Doppler, B+i- Color Doppler. B+PWD±Co… | 2007 |
| * | — | Acuson Antares Ultrasound System Named without a submission number | |
| * | — | 32000 Ultrasound System Named without a submission number |
What descends from it? (198)
See all 1983 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 17 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 19 of the 64 ancestors have a recall of any class.
- Of its descendants, K130739 (Siemens Medical Solutions USA, Inc., 2013) has gone furthest, with 177 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. 2012, 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 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…
Read the full statement (232 words)
The 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 Ultrsound 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121138: Acuson S3000 Diagnostic 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/K121138
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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