510(k) · Cleared
ClearedAcuson S2000 Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Nov 13, 2007 as substantially equivalent to K063803 (Siemens Medical Solutions USA, Inc., Ultrasound DI, 2007) and 2 other predicates after a 43-day review. Its family tree reaches back 10 generations to 1995. 2 of the 859 devices in its family, counting itself, have a Class I recall. 800 later devices descend from it.
- Decided
- Nov 13, 2007
- Review
- 43 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K935595 (1995). 58 ancestors in all, the oldest K891689 (1989). 800 later devices descend from it, 16 citing it directly. 2 of the 859 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 6 generations between
- 3 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 2 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 1 generation backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- This deviceK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- Descendant · cites it directly · 588 of its ownK093563 IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · Recalled
- Descendant · cites it directly · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- Descendant · 2 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- Descendant · cites it directly · 528 of its ownK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
- Descendant · cites it directly · 527 of its ownK102041 AixplorerSupersonic Imagine · 2010
Show all 10 generations
- Root · 10 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 9 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 8 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 7 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 6 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 5 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 4 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 3 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 2 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 1 generation backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- This deviceK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
Showing 5 of 800 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 800 · See all- K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · cites it directly588descendants
- K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · cites it directly582descendants
- K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 2 generations on569descendants
- K091970Aixplorer Ultrasound SystemSupersonic Imagine · 2009 · cites it directly528descendants
- K102041AixplorerSupersonic Imagine · 2010 · cites it directly527descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −9 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −8 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −7 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −6 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −5 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −4 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −3 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −2 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −1 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| 0 (this device) | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +1 | K093563 | IU22 Ultrasound System and Transducers | Philips Ultrasound, Inc. | 2010 | 2 |
| +1 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| +2 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| +1 | K091970 | Aixplorer Ultrasound System | Supersonic Imagine | 2009 | — |
| +1 | K102041 | Aixplorer | Supersonic Imagine | 2010 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 9 | 0 |
| 2011 | 18 | 0 |
| 2012 | 27 | 0 |
| 2013 | 32 | 0 |
| 2014 | 45 | 0 |
| 2015 | 49 | 0 |
| 2016 | 58 | 0 |
| 2017 | 69 | 0 |
| 2018 | 61 | 0 |
| 2019 | 46 | 0 |
| 2020 | 63 | 0 |
| 2021 | 48 | 0 |
| 2022 | 52 | 0 |
| 2023 | 50 | 0 |
| 2024 | 54 | 0 |
| 2025 | 65 | 2 |
| 2026 | 46 | 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.
2 devices in this family have a Class I recall. 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 1…892.1560 Product Code 90-IYO Diagnostic Ultrasound Transducer FR # 892.1570 Product Code 90-ITX 3. Predicate Device: K063803, 11/22/2006, Acuson Antares Diagnostic Ultrasound System K063085, 11/14/2006, Acuson Sequoia Diagnostic Ultrasound Syst… | 2007 |
| * | K063085 | Modification to Acuson Sequoia Ultrasound SystemSummary page 1…er FR # 892.1570 Product Code 90-ITX 3. Predicate Device: K063803, 11/22/2006, Acuson Antares Diagnostic Ultrasound System K063085, 11/14/2006, Acuson Sequoia Diagnostic Ultrasound System K032620, 10/1 0/2003, GE Voluson 730 Ultrasound System 4.… | 2006 |
| * | K032620 | GE Voluson 730 Pro/Expert BT03 Ultrasound SystemSummary page 1…e Device: K063803, 11/22/2006, Acuson Antares Diagnostic Ultrasound System K063085, 11/14/2006, Acuson Sequoia Diagnostic Ultrasound System K032620, 10/1 0/2003, GE Voluson 730 Ultrasound System 4. Device Description: The Acuson S 2 0 0 0TM Ultrasound System… | 2003 |
What descends from it? (800)
See all 80016 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093563 | IU22 Ultrasound System and Transducers | 2010 | 588 |
| K083095 | Sonixtouch Ultrasound System | 2008 | 582 |
| K091970 | Aixplorer Ultrasound System | 2009 | 528 |
| K102041 | Aixplorer | 2010 | 527 |
| K121329 | Aixplorer | 2012 | 405 |
| K081148 | Siemens Acuson 2000 Ultrasound System with Abvs Transducer | 2008 | 325 |
| K111674 | Acuson | 2011 | 223 |
| K121138 | Acuson S3000 Diagnostic Ultrasound System | 2012 | 198 |
| K112596 | Acuson S2000 Diagnostic Ultrasound System | 2011 | 192 |
| K082326 | Zonare Ultra Ultrasound System | 2008 | 133 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 15 of the 58 ancestors have a recall of any class.
- Of its descendants, K093563 (Philips Ultrasound, Inc., 2010) has gone furthest, with 588 descendants of its own.
- 2 other devices also cite its predicate K063803.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The S 2 0 0 0 TM 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 (100 words)
The S 2 0 0 0 TM 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072786 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072786: Acuson S2000 Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072786
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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