510(k) · Cleared
ClearedModification to Acuson X300 Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc., Ultrasound DI · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on May 16, 2007 as substantially equivalent to K061946 (Siemens Medical Solutions USA, Inc., 2006) after a 34-day review. Its family tree reaches back 9 generations to 1995. 427 later devices descend from it.
- Decided
- May 16, 2007
- Review
- 34 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K935595 (1995). 39 ancestors in all, the oldest K921148 (1992). 427 later devices descend from it, 6 citing it directly.
- Root · 9 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 5 generations between
- 3 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 2 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 1 generation backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- This deviceK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- Descendant · cites it directly · 330 of its ownK083149 Arterial Health Package (Ahp) SoftwareSiemens Medical Solutions USA, Inc. · 2009
- Descendant · cites it directly · 279 of its ownK072676 Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · cites it directly · 278 of its ownK080760 Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008
- Descendant · cites it directly · 277 of its ownK090276 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2009
- Descendant · cites it directly · 189 of its ownK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
Show all 9 generations
- Root · 9 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 8 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 7 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 6 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 5 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 4 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 3 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 2 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 1 generation backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- This deviceK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
Showing 5 of 427 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 427 · See all- K083149Arterial Health Package (Ahp) SoftwareSiemens Medical Solutions USA, Inc. · 2009 · cites it directly330descendants
- K072676Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · cites it directly279descendants
- K080760Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008 · cites it directly278descendants
- K090276Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2009 · cites it directly277descendants
- K072090Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · cites it directly189descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −8 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −7 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −6 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −5 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −4 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −3 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −2 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −1 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| 0 (this device) | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| +1 | K083149 | Arterial Health Package (Ahp) Software | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +1 | K072676 | Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | 5 |
| +1 | K080760 | Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008 | — |
| +1 | K090276 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +1 | K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1997 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 7 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 6 | 0 |
| 2010 | 6 | 0 |
| 2011 | 11 | 0 |
| 2012 | 11 | 0 |
| 2013 | 18 | 0 |
| 2014 | 9 | 0 |
| 2015 | 22 | 0 |
| 2016 | 16 | 0 |
| 2017 | 39 | 0 |
| 2018 | 24 | 0 |
| 2019 | 22 | 0 |
| 2020 | 42 | 0 |
| 2021 | 26 | 0 |
| 2022 | 30 | 0 |
| 2023 | 26 | 0 |
| 2024 | 39 | 0 |
| 2025 | 50 | 0 |
| 2026 | 27 | 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 |
|---|---|---|---|
| * | K061946 | Acuson 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 (K06 1946). B. Device Description: The Siemens Acuson X300 has been designed to meet the following product safety standards:… | 2006 |
What descends from it? (427)
See all 4276 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083149 | Arterial Health Package (Ahp) Software | 2009 | 330 |
| K072676 | Acuson X300 Ultrasound System | 2007 | 279 |
| K080760 | Acuson X300 Ultrasound System | 2008 | 278 |
| K090276 | Acuson X300 Diagnostic Ultrasound System | 2009 | 277 |
| K072090 | Siemens Diagnostic Ultrasound Systems | 2007 | 189 |
| K093531 | Acuson Model X300 Diagnostic Ultrasound System | 2009 | 99 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 12 of the 39 ancestors have a recall of any class.
- Of its descendants, K083149 (Siemens Medical Solutions USA, Inc., 2009) has gone furthest, with 330 descendants of its own.
- 5 other devices also cite its predicate K061946.
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. 2007, 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?
Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or…
Read the full statement (288 words)
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071036 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071036: Modification to Acuson X300 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/K071036
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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