510(k) · Cleared
Recalled · 2012Acuson
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 30, 2011 as substantially equivalent to K063803 (Siemens Medical Solutions USA, Inc., Ultrasound DI, 2007) and 6 other predicates after a 15-day review. Its family tree reaches back 12 generations to 1995. 223 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 30, 2011
- Review
- 15 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 3
- Predicates
- 7
Its longest line of descent runs back 12 generations to K935595 (1995). 63 ancestors in all, the oldest K891689 (1989). 223 later devices descend from it, 6 citing it directly.
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 8 generations between
- 3 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 2 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 1 generation backK081148 Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008 · Recalled
- This deviceK111674 AcusonSiemens Medical Solutions USA, Inc. · 2011
- Descendant · cites it directly · 198 of its ownK121138 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 · 124 of its ownK131164 AcusonSiemens 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
Show all 12 generations
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 10 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 9 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 8 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 7 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 6 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 5 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 4 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 3 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 2 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 1 generation backK081148 Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008 · Recalled
- This deviceK111674 AcusonSiemens Medical Solutions USA, Inc. · 2011
Showing 5 of 223 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 223 · See all- K121138Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution · 2012 · cites it directly198descendants
- K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2013 · cites it directly177descendants
- K131164AcusonSiemens Medical Solutions USA, Inc. · 2013 · cites it directly124descendants
- K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc. · 2013 · cites it directly116descendants
- K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013 · 2 generations on102descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −11 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −10 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −9 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −8 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −7 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −6 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −5 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −4 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −3 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −2 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −1 | K081148 | Siemens Acuson 2000 Ultrasound System with Abvs Transducer | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008 | 3 |
| 0 (this device) | K111674 | Acuson | Siemens Medical Solutions USA, Inc. | 2011 | — |
| +1 | 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 | K131164 | Acuson | 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 | — |
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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 8 | 0 |
| 2014 | 10 | 0 |
| 2015 | 10 | 0 |
| 2016 | 16 | 0 |
| 2017 | 19 | 0 |
| 2018 | 20 | 0 |
| 2019 | 18 | 0 |
| 2020 | 18 | 0 |
| 2021 | 19 | 0 |
| 2022 | 21 | 0 |
| 2023 | 16 | 0 |
| 2024 | 15 | 0 |
| 2025 | 20 | 0 |
| 2026 | 11 | 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? (7)
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 |
|---|---|---|---|
| * | K063803 | Acuson Antares Diagnostic Ultrasound SystemSummary page 8…BMDC Note 3,4,6,10 Neonatal Cardiac _____________, N new Indication: P =previously cleared by FDA K063085. K063803. K072786. K081 148, K082142, K090334, K093812 Note 1 For example: breast, testes, thyroid, penis, prostate. etc.… | 2007 |
| * | K093812 | Acuson S2000 Diagnostic Ultrasound SystemSummary 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 (K093812, K090334, K072786, K081 148), and Siemens V7M (K063085), AcuNav 8F and AcuNav 1lOF (K071234) transducers. These predicates are le… | 2010 |
| * | K090334 | Acuson S2000 Diagnostic Ultrasound SystemSummary page 1…oppler 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 (K093812, K090334, K072786, K081 148), and Siemens V7M (K063085), AcuNav 8F and AcuNav 1lOF (K071234) transducers. These predicates are legally mar… | 2009 |
| * | K072786 | Acuson S2000 Ultrasound SystemSummary page 1…de, a combination of modes, or Harmonic Imaging and 3D14D Imaging on a Flat Panel Display. It is substantially equivalent to our current S2000 product (K093812, K090334, K072786, K081 148), and Siemens V7M (K063085), AcuNav 8F and AcuNav 1lOF (K071234) transducers. These predicates are legally marketed dev… | 2007 |
| * | K081148 | Siemens Acuson 2000 Ultrasound System with Abvs TransducerSummary page 1…bination of modes, or Harmonic Imaging and 3D14D Imaging on a Flat Panel Display. It is substantially equivalent to our current S2000 product (K093812, K090334, K072786, K081 148), and Siemens V7M (K063085), AcuNav 8F and AcuNav 1lOF (K071234) transducers. These predicates are legally marketed devices. 5.… | 2008 |
| * | K063085 | Modification to Acuson Sequoia Ultrasound SystemSummary page 1…ic Imaging and 3D14D Imaging on a Flat Panel Display. It is substantially equivalent to our current S2000 product (K093812, K090334, K072786, K081 148), and Siemens V7M (K063085), AcuNav 8F and AcuNav 1lOF (K071234) transducers. These predicates are legally marketed devices. 5. Intended Use The S20 0 0 T… | 2006 |
| * | K071234 | Acunav Diagnostic Ultrasound Catheter 8F and 10FSummary page 1…t Panel Display. It is substantially equivalent to our current S2000 product (K093812, K090334, K072786, K081 148), and Siemens V7M (K063085), AcuNav 8F and AcuNav 1lOF (K071234) transducers. These predicates are legally marketed devices. 5. Intended Use The S20 0 0 TM ultrasound imaging systems are inte… | 2007 |
What descends from it? (223)
See all 2236 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 25, 2012 | Not classified | Z-1616-2012 | Software design | When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale. |
| Apr 23, 2012 | Not classified | Z-1684-2012 | Software change control | When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale. |
| Apr 23, 2012 | Not classified | Z-1685-2012 | Software change control | When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 18 of the 63 ancestors have a recall of any class.
- Of its descendants, K121138 (Siemens Medical Solution, 2012) has gone furthest, with 198 descendants of its own.
- 2 other devices also cite its predicate K063803.
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. 2011, 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 S2000OTM ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraolperative, Pediatric, Small Parts, Trariscranial, 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 (232 words)
The S2000OTM ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraolperative, Pediatric, Small Parts, Trariscranial, 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/K111674 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111674: Acuson.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111674
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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