510(k) · Cleared
Recalled · 2010Acuson S2000 Diagnostic Ultrasound System
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 Mar 3, 2010 after an 82-day review. The FDA summary names its predicate without a number. 322 later devices descend from it. It has been recalled once.
- Decided
- Mar 3, 2010
- Review
- 82 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 0
322 later devices descend from it, 3 citing it directly.
- This deviceK093812 Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2010
- Descendant · cites it directly · 223 of its ownK111674 AcusonSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- Descendant · cites it directly · 198 of its ownK121138 Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution · 2012
- Descendant · cites it directly · 192 of its ownK112596 Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2011
- Descendant · 2 generations on · 177 of its ownK130739 Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2013
- Descendant · 2 generations on · 124 of its ownK131164 AcusonSiemens Medical Solutions USA, Inc. · 2013
Showing 5 of 322 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 322 · See all- K111674AcusonSiemens Medical Solutions USA, Inc. · 2011 · cites it directly223descendants
- K121138Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution · 2012 · cites it directly198descendants
- K112596Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2011 · cites it directly192descendants
- K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2013 · 2 generations on177descendants
- K131164AcusonSiemens Medical Solutions USA, Inc. · 2013 · 2 generations on124descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093812 | Acuson S2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2010 | — |
| +1 | K111674 | Acuson | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| +1 | K121138 | Acuson S3000 Diagnostic Ultrasound System | Siemens Medical Solution | 2012 | — |
| +1 | K112596 | Acuson S2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2011 | — |
| +2 | K130739 | Acuson S2000 and S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +2 | K131164 | Acuson | Siemens Medical Solutions USA, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 12 | 0 |
| 2014 | 12 | 0 |
| 2015 | 19 | 0 |
| 2016 | 23 | 0 |
| 2017 | 28 | 0 |
| 2018 | 28 | 0 |
| 2019 | 27 | 0 |
| 2020 | 25 | 0 |
| 2021 | 27 | 0 |
| 2022 | 25 | 0 |
| 2023 | 21 | 0 |
| 2024 | 26 | 0 |
| 2025 | 25 | 0 |
| 2026 | 14 | 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? (1)
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 |
|---|---|---|---|
| * | — | Acuson Antares Ultrasound System Named without a submission number |
What descends from it? (322)
See all 3223 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 |
|---|---|---|---|---|
| Mar 1, 2010 | Not classified | Z-1832-2011 | Software design | "Any 2D measurement performed in Exam Review or offline, on a zoomed Retrospective clip capture may be erroneous. This applies to 2D, 2D/PW, 2D/CW and 2D/M-mode." |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K111674 (Siemens Medical Solutions USA, Inc., 2011) has gone furthest, with 223 descendants of its own.
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. 2010, 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 S2000TM 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 (197 words)
The S2000TM 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 CASE 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'.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093812 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093812: Acuson S2000 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093812
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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