510(k) · Cleared
Recalled · Class II · 2015Siemens Acuson 2000 Ultrasound System with Abvs Transducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc., Ultrasound DI · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Dec 22, 2008 as substantially equivalent to K072786 (Siemens Medical Solutions USA, Inc., 2007) after a 244-day review. Its family tree reaches back 11 generations to 1995. 325 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 22, 2008
- Review
- 244 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 11 generations to K935595 (1995). 59 ancestors in all, the oldest K891689 (1989). 325 later devices descend from it, 6 citing it directly.
- Root · 11 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 7 generations between
- 3 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 2 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 1 generation backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- This deviceK081148 Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008
- 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
Show all 11 generations
- Root · 11 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 10 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 9 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 8 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 7 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 6 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 5 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 4 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 3 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 2 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 1 generation backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- This deviceK081148 Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008
Showing 5 of 325 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 325 · 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 |
|---|---|---|---|---|---|
| −11 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −10 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −9 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −8 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −7 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −6 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −5 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −4 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −3 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −2 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −1 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| 0 (this device) | K081148 | Siemens Acuson 2000 Ultrasound System with Abvs Transducer | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008 | — |
| +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 | — |
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 |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 12 | 0 |
| 2014 | 12 | 0 |
| 2015 | 21 | 0 |
| 2016 | 23 | 0 |
| 2017 | 28 | 0 |
| 2018 | 28 | 0 |
| 2019 | 28 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K072786 | Acuson S2000 Ultrasound SystemSummary page 1…0 Product Code 90-ITX A. Legally Marketed Predicate Devices ‘The Acuson $2000 ABVS Ultrasound system is substantially equivalent to the Acuson S2000 ultrasound system (K072786)and the U-Systems ultrasound system.. B. Device Description: The Acuson $2000 ABVS Ultrasound System has been designed to meet… | 2007 |
| * | — | U-Systems ultrasound system Named without a submission number |
What descends from it? (325)
See all 3256 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111674 | Acuson | 2011 | 223 |
| K121138 | Acuson S3000 Diagnostic Ultrasound System | 2012 | 198 |
| K112596 | Acuson S2000 Diagnostic Ultrasound System | 2011 | 192 |
| K190314 | Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 | 2019 | 0 |
| K151709 | Hi-Light Diagnostic Ultrasound Systems | 2015 | 0 |
| K150580 | UltraVision 2 Diagnostic Ultrasound System | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 12, 2015 | Class II | Z-1063-2015 | Vendor change control | There is a low probability the scanner arm will become completely detached from the scanner column. |
| Jan 18, 2013 | Class II | Z-0930-2013 | Process design | On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges. |
| Mar 28, 2011 | Not classified | Z-2150-2011 | Process change control | The weld connecting the ABVS arm to the system base has the potential to fail, causing the arm to fall off of the unit. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 15 of the 59 ancestors have a recall of any class.
- Of its descendants, K111674 (Siemens Medical Solutions USA, Inc., 2011) has gone furthest, with 223 descendants of its own.
- 15 other devices also cite its predicate K072786.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The Modified $2000, the $2000 ABVS Ultrasound System, is intended for the following applications: General Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system supports the transducers listed in the Ultrasound Indications for Use tables, including the 14LSBV for B-mode imaging of…
Read the full statement (114 words)
The Modified $2000, the $2000 ABVS Ultrasound System, is intended for the following applications: General Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system supports the transducers listed in the Ultrasound Indications for Use tables, including the 14LSBV for B-mode imaging of a patient’s breast using an optional automatic scanning function. The device is not intended to be used as a replacement for screening mammography.
The system also provides for the measurement of anatomical structures and analysis as provided in the original $2000 Ultrasound System, which provides information that is used by medical health care professionals for clinical diagnosis purposes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K081148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081148: Siemens Acuson 2000 Ultrasound System with Abvs Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081148
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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