510(k) · Cleared
Recalled · Class II · 2019ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite 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 Aug 15, 2017 as substantially equivalent to K161787 (Siemens Medical Solutions USA, Inc., 2016) and 1 other predicate after an 8-day review. Its family tree reaches back 23 generations to 1995. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Aug 15, 2017
- Review
- 8 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 23 generations to K935595 (1995). 183 ancestors in all, the oldest K863700 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 23 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 19 generations between
- 3 generations backK152369 ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group · 2015
- 2 generations backK162243 ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016
- 1 generation backK163635 ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group · 2017 · Recalled
- This deviceK172374 ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic…Siemens Medical Solutions USA, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK173981 ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic…Siemens Medical Solutions USA, Inc. Ultrasound Group · 2018 · Recalled
Show all 23 generations
- Root · 23 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 22 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 21 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 20 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 19 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 18 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 17 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 16 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 15 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 14 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 13 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 12 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 11 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 10 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 9 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 8 generations backK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
- 7 generations backK123001 Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- 6 generations backK132804 Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · Recalled
- 5 generations backK140959 Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014
- 4 generations backK142876 ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- 3 generations backK152369 ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group · 2015
- 2 generations backK162243 ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016
- 1 generation backK163635 ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group · 2017 · Recalled
- This deviceK172374 ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic…Siemens Medical Solutions USA, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −22 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −21 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −20 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −19 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −18 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −17 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −16 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −15 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −14 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −13 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −12 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −11 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −10 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −9 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −8 | K121699 | Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −7 | K123001 | Acuson X700 Diagnstic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2012 | 2 |
| −6 | K132804 | Acuson S1000 / S2000 / S3000 | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013 | 3 |
| −5 | K140959 | Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −4 | K142876 | ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | 1 |
| −3 | K152369 | ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2015 | — |
| −2 | K162243 | ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2016 | — |
| −1 | K163635 | ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2017 | 1 |
| 0 (this device) | K172374 | ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic… | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +1 | K173981 | ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic… | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2018 | 2 |
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 | 12 | 0 |
| 2003 | 13 | 0 |
| 2004 | 16 | 0 |
| 2005 | 12 | 0 |
| 2006 | 8 | 0 |
| 2007 | 9 | 0 |
| 2008 | 9 | 0 |
| 2009 | 8 | 0 |
| 2010 | 8 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 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? (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 |
|---|---|---|---|
| * | K161787 | ACUSON NX2 Diagnostic Ultrasound SystemsSummary page 4…Peripheral vessel P P P P P BMDC Vessel Other (Specify) N = new indication; P = previously cleared (K161787) Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: abdominal, vascular… | 2016 |
| * | K163635 | ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSummary page 13…Intra-cardiac Other (Specify) Peripheral Peripheral vessel Vessel Other (Specify) N = new indication; P = previously cleared (K163635) Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: abdominal, vascular… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173981 | ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 28, 2019 | Class II | Z-2350-2019 | Software design | The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not… |
| Jan 28, 2019 | Class II | Z-2351-2019 | Software design | The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 50 of the 183 ancestors have a recall of any class.
- Of its descendants, K173981 (Siemens Medical Solutions USA, Inc. Ultrasound Group, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K161787.
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. 2017, 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 ACUSON NX2 and NX2 Elite diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical…
Read the full statement (199 words)
The ACUSON NX2 and NX2 Elite diagnostic ultrasound imaging systems are intended for the following applications:
Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic,
Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications.
The systems also provide for the measurement of anatomical structures and for analysis packages that provide information
that is used for clinical diagnosis purposes.
Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic
villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and
regulations.
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 the state of their cardiovascular system.
Note: This feature can 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
Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular
Medicine."
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172374 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172374: ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic 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/K172374
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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