510(k) · Cleared
Recalled · Class II · 2015Acuson X700 Diagnstic 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 Oct 26, 2012 as substantially equivalent to K121699 (Siemens Medical Solutions USA, Inc., 2012) and 3 other predicates after a 29-day review. Its family tree reaches back 16 generations to 1995. 74 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 26, 2012
- Review
- 29 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 16 generations to K935595 (1995). 159 ancestors in all, the oldest K863700 (1987). 74 later devices descend from it, 4 citing it directly.
- Root · 16 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 12 generations between
- 3 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 2 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 1 generation backK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
- This deviceK123001 Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012
- Descendant · cites it directly · 73 of its ownK132804 Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · Recalled
- Descendant · 2 generations on · 60 of its ownK140959 Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014
- Descendant · cites it directly · 58 of its ownK142876 ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 54 of its ownK152369 ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group · 2015
- Descendant · 3 generations on · 49 of its ownK162243 ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016
Show all 16 generations
- Root · 16 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 15 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 14 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 13 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 12 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 11 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 10 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 9 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 8 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 7 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 6 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 5 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 4 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 3 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 2 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 1 generation backK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
- This deviceK123001 Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 74 · See all- K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · cites it directly73descendants
- K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014 · 2 generations on60descendants
- K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014 · cites it directly58descendants
- K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group · 2015 · 2 generations on54descendants
- K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016 · 3 generations on49descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −15 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −14 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −13 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −12 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −11 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −10 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −9 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −8 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −7 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −6 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −5 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −4 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −3 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −2 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −1 | K121699 | Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2012 | — |
| 0 (this device) | K123001 | Acuson X700 Diagnstic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2012 | — |
| +1 | K132804 | Acuson S1000 / S2000 / S3000 | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013 | 3 |
| +2 | K140959 | Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | — |
| +1 | K142876 | ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | 1 |
| +2 | K152369 | ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2015 | — |
| +3 | K162243 | ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1996 | 2 | 0 |
| 1997 | 6 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 9 | 0 |
| 2002 | 10 | 0 |
| 2003 | 12 | 0 |
| 2004 | 16 | 0 |
| 2005 | 12 | 0 |
| 2006 | 8 | 0 |
| 2007 | 9 | 0 |
| 2008 | 9 | 0 |
| 2009 | 7 | 0 |
| 2010 | 6 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 7 | 0 |
| 2022 | 8 | 0 |
| 2023 | 6 | 0 |
| 2024 | 7 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121699 | Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSummary page 1…iagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product, the Siemens ACUSON X300 ultrasound system (K1 21699), ACUSON S2000 ultrasound system (K1 12596) and Ultrasonix SonixTABLET ultrasound scanner (K1 13663, K102997). B. Device Descrip… | 2012 |
| * | K112596 | Acuson S2000 Diagnostic Ultrasound SystemSummary page 1…s and proprietary software, and is substantially equivalent to our current product, the Siemens ACUSON X300 ultrasound system (K1 21699), ACUSON S2000 ultrasound system (K1 12596) and Ultrasonix SonixTABLET ultrasound scanner (K1 13663, K102997). B. Device Description: The Siemens ACUSON X 7 00 TM is a mul… | 2011 |
| * | K113663 | Sonixtablet Ultrasound ScannerSummary page 1…nt to our current product, the Siemens ACUSON X300 ultrasound system (K1 21699), ACUSON S2000 ultrasound system (K1 12596) and Ultrasonix SonixTABLET ultrasound scanner (K1 13663, K102997). B. Device Description: The Siemens ACUSON X 7 00 TM is a multi-purpose mobile, software controlled, diagnostic ultras… | 2012 |
| * | K102997 | Sonixtablet Ultrasound ScannerSummary page 1…current product, the Siemens ACUSON X300 ultrasound system (K1 21699), ACUSON S2000 ultrasound system (K1 12596) and Ultrasonix SonixTABLET ultrasound scanner (K1 13663, K102997). B. Device Description: The Siemens ACUSON X 7 00 TM is a multi-purpose mobile, software controlled, diagnostic ultrasound syst… | 2010 |
What descends from it? (74)
See all 744 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 |
|---|---|---|---|---|
| Sep 5, 2015 | Class II | Z-1572-2016 | Software design | Due to a communication error between the software and V5Ms transducers rotation function, ACUSON X700 ultrasound systems at software versions 1.1.04, display an IMG_15 error message causes the system to lock up, which requires a reboot to… |
| Apr 2, 2014 | Class II | Z-1504-2014 | Software Design Change | When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology study, data from the previous patient could replace the current patient's date in the report. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 40 of the 159 ancestors have a recall of any class.
- Of its descendants, K132804 (Siemens Medical Solutions USA, Inc. Ultrasound Gro, 2013) has gone furthest, with 73 descendants of its own.
- 6 other devices also cite its predicate K121699.
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. 2012, 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 Siemens ACUSON X 7 00 TM ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications. The…
Read the full statement (209 words)
The Siemens ACUSON X 7 00 TM ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K123001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123001: Acuson X700 Diagnstic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123001
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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