510(k) Report

510(k) · Cleared

Cleared

Acuson S2000 and S3000

K130881510(k) TraditionalCleared Oct 11, 2013196-day reviewClass II21 CFR 892.1550

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siemens Medical Solutions USA, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Oct 11, 2013 as substantially equivalent to K111674 (Siemens Medical Solutions USA, Inc., 2011) and 3 other predicates after a 196-day review. Its family tree reaches back 14 generations to 1995. 116 later devices descend from it.

Decided
Oct 11, 2013
Review
196 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). 116 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 2 other ancestors2010: 3 other ancestors2009: 2 other ancestors2007: 1 other ancestor2006: 1 other ancestor2005: 4 other ancestors2004: 10 other ancestors2003: 5 other ancestors2002: 7 other ancestors2001: 3 other ancestors2000: 6 other ancestors1999: 7 other ancestors1997: 4 other ancestors1995: 4 other ancestors1998: 1 other ancestor1994: 4 other ancestors1992: 1 other ancestor1989: 1 other ancestor2015: 5 descendants cleared2016: 11 descendants cleared2017: 11 descendants cleared2018: 14 descendants cleared2019: 12 descendants cleared2023: 9 descendants cleared2021: 12 descendants cleared2020: 7 descendants cleared2022: 12 descendants cleared2025: 11 descendants cleared2026: 6 descendants cleared2024: 6 descendants clearedK935595 · Acuson Model 3001 · Acuson Corp. · 1995K973767 · Harmonic Imaging with Contrast · Acuson Corp. · 1997K022567 · Sequoia Signature II Diagnostic Ultrasound System · Acuson Corp. · 2002K032114 · Sequoia 8.0 Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · 2003×3: 3 generations cleared close together, K041319 (2004), K042770 (2004), K050240 (2005) K052894 · Sonoline G60 S Ultrasound System · Siemens Medical Solutions USA, Inc. · 2005 · recalled×2: 2 generations cleared close together, K063138 (2006), K063803 (2007) K072786 · Acuson S2000 Ultrasound System · Siemens Medical Solutions USA, Inc. · 2007K081148 · Siemens Acuson 2000 Ultrasound System with Abvs Transducer · Siemens Medical Solutions USA, Inc., Ultrasound DI · 2008 · recalledK111674 · Acuson · Siemens Medical Solutions USA, Inc. · 2011 · recalledK121138 · Acuson S3000 Diagnostic Ultrasound System · Siemens Medical Solution · 20121990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 7 other ancestors3 generations back: 8 other ancestors4 generations back: 13 other ancestors5 generations back: 9 other ancestors6 generations back: 9 other ancestors7 generations back: 9 other ancestors8 generations back: 9 other ancestors 1 generation forward: 5 descendants2 generations forward: 14 descendants3 generations forward: 19 descendants4 generations forward: 17 descendants5 generations forward: 17 descendants6 generations forward: 15 descendants7 generations forward: 12 descendants8 generations forward: 7 descendants9 generations forward: 3 descendants10 generations forward: 4 descendants11 generations forward: 2 descendants12 generations forward: 1 descendant K121138 · Acuson S3000 Diagnostic Ultrasound System · Siemens Medical Solution · 2012K111674 · Acuson · Siemens Medical Solutions USA, Inc. · 2011 · recalledK081148 · Siemens Acuson 2000 Ultrasound System with Abvs Transducer · Siemens Medical Solutions USA, Inc., Ultrasound DI · 2008 · recalledK072786 · Acuson S2000 Ultrasound System · Siemens Medical Solutions USA, Inc. · 2007K063803 · Acuson Antares Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · recalledK063138 · Modification to Acuson Antares Ultrasound System · Siemens Medical Solutions USA, Inc. · 2006K052894 · Sonoline G60 S Ultrasound System · Siemens Medical Solutions USA, Inc. · 2005 · recalledK050240 · Modification to Acuson CV70 Cardiovascular System · Siemens Medical Solutions USA, Inc. · 2005 · recalledK042770 · Modification to Acuson CV70 Cardiovascular System · Siemens Medical Solutions USA, Inc. · 2004 · recalledK041319 · Sequoia Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · 2004K032114 · Sequoia 8.0 Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · 2003K022567 · Sequoia Signature II Diagnostic Ultrasound System · Acuson Corp. · 2002K973767 · Harmonic Imaging with Contrast · Acuson Corp. · 1997K935595 · Acuson Model 3001 · Acuson Corp. · 1995−10−50+5+10
  1. Root · 14 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
  2. 10 generations between
  3. 3 generations backK081148 Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008 · Recalled
  4. 2 generations backK111674 AcusonSiemens Medical Solutions USA, Inc. · 2011 · Recalled
  5. 1 generation backK121138 Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution · 2012
  6. This deviceK130881 Acuson S2000 and S3000Siemens Medical Solutions USA, Inc. · 2013
  7. Descendant · cites it directly · 96 of its ownK151663 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
  8. Descendant · 2 generations on · 90 of its ownK152962 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
  9. Descendant · 2 generations on · 89 of its ownK153529 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · Recalled
  10. Descendant · 2 generations on · 65 of its ownK153408 HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
  11. Descendant · 2 generations on · 64 of its ownK162094 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016
Show all 14 generations
  1. Root · 14 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
  2. 13 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
  3. 12 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
  4. 11 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
  5. 10 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
  6. 9 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
  7. 8 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
  8. 7 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
  9. 6 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
  10. 5 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
  11. 4 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
  12. 3 generations backK081148 Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008 · Recalled
  13. 2 generations backK111674 AcusonSiemens Medical Solutions USA, Inc. · 2011 · Recalled
  14. 1 generation backK121138 Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution · 2012
  15. This deviceK130881 Acuson S2000 and S3000Siemens Medical Solutions USA, Inc. · 2013

Showing 5 of 116 descendants. See all descendants

Descendants cleared per year

2015: 52016: 112017: 112018: 142019: 122020: 72021: 122022: 122023: 92024: 62025: 112026: 6
2015high 14 (2018) · low 5 (2015)2026

Most influential descendants

Showing 5 of 116 · 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

GenerationNumberDeviceApplicantDecidedRecalls
−14K935595Acuson Model 3001Acuson Corp.1995—
−13K973767Harmonic Imaging with ContrastAcuson Corp.1997—
−12K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp.2002—
−11K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2003—
−10K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004—
−9K042770Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20041
−8K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20051
−7K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc.20051
−6K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006—
−5K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20079
−4K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc.2007—
−3K081148Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI20083
−2K111674AcusonSiemens Medical Solutions USA, Inc.20113
−1K121138Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution2012—
0 (this device)K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013—
+1K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2015—
+2K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2015—
+2K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20161
+2K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2015—
+2K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199210
199440
199540
199740
199810
199970
200060
200130
200270
200350
2004100
200540
200610
200710
200920
201030
201220

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201550
2016110
2017110
2018140
2019120
202070
2021120
2022120
202390
202460
2025110
202660
FIG. 1 — Lineage of K130881, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K111674Acuson
Summary page 1
…on S2000 and S3000 Ultrasound Systems are substantially equivalent to the company' sown S2000 and S3000 Ultrasound Systems and Supersonic Imagine Shearwave Elastography (K1 11674, K(121138,112255, K121329) 4. Device Description: The S2000 and S3000 Ultrasound Systems are multi-purpose mobile, software contr…
Siemens Medical Solutions USA, Inc.20113
*K121138Acuson S3000 Diagnostic Ultrasound System
Summary page 1
…pler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. It is substantially equivalent to the S2000 (1111674) and S3000 system (K121138) which are legally marketed devices. 5. Intended Use The S2000 and S3000 ultrasound imaging systems are intended for the follow…
Siemens Medical Solution2012—
*K112255Aixplorer
Summary page 2
…acteristic Device Device S3000 S2000 Imagine 82000 83000 K(121 138 1 1167 K1122551 74 K121 329 Indications for Us…
Supersonic Imagine2012—
*K121329Aixplorer
Summary page 1
…nd Systems are substantially equivalent to the company' sown S2000 and S3000 Ultrasound Systems and Supersonic Imagine Shearwave Elastography (K1 11674, K(121138,112255, K121329) 4. Device Description: The S2000 and S3000 Ultrasound Systems are multi-purpose mobile, software controlled diagnostic ultrasoun…
Supersonic Imagine2012—

Also cleared against K111674: 5 other devices →

What descends from it? (116)

See all 116

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596
K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.201558
K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.20179
K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160
K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150

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, 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 devices

IYN 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

2007: 132008: 252009: 182010: 292011: 392012: 432013: 512014: 562015: 542016: 602017: 642018: 592019: 472020: 572021: 462022: 532023: 442024: 502025: 572026 (partial year): 44
2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007: 26 days median2008: 18 days median2009: 29 days median2010: 67 days median2011: 46 days median2012: 37 days median2013: 60 days median2014: 39 days median2015: 55 days median2016: 56 days median2017: 83 days median2018: 85 days median2019: 79 days median2020: 72 days median2021: 105 days median2022: 105 days median2023: 115 days median2024: 119 days median2025: 124 days median2026 (partial year): 107 days median
2007high 124 (2025) · low 18 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYN

10in 2025

2007: 162008: 122009: 82010: 102011: 82012: 32013: 82014: 22015: 32016: 22018: 72020: 42021: 82022: 102023: 42024: 12025: 102026 (partial year): 2, 1 Class I
2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007: 32008: 22009: 92010: 172011: 182012: 202013: 182014: 482015: 1162016: 1452017: 1462018: 852019: 592020: 672021: 2132022: 1862023: 2292024: 2662025: 610
2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071326163
20082518122
2009182989
201029671017
20113946818
20124337320
20135160818
20145639248
201554553116
201660562145
201764830146
20185985785
20194779059
20205772467
2021461058213
20225310510186
2023441154229
2024501191266
20255712410610
2026441072 (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, OBIGYN, 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, intraoiperative, intraoiperative neurological, pediatric…

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, OBIGYN, 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, intraoiperative, intraoiperative 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.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K130881: Acuson S2000 and S3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130881

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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