510(k) · Cleared
Recalled · 2008Acuson X300 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 Jul 21, 2006 as substantially equivalent to K050034 (Siemens Medical Solutions USA, Inc., 2005) and 3 other predicates after an 11-day review. Its family tree reaches back 8 generations to 1995. 428 later devices descend from it. It has been recalled once.
- Decided
- Jul 21, 2006
- Review
- 11 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 8 generations to K935595 (1995). 38 ancestors in all, the oldest K921148 (1992). 428 later devices descend from it, 6 citing it directly.
- Root · 8 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 7 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 6 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 5 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 4 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 3 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 2 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 1 generation backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- This deviceK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- Descendant · cites it directly · 427 of its ownK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- Descendant · 2 generations on · 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
Showing 5 of 428 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 428 · See all- K071036Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · cites it directly427descendants
- K083149Arterial Health Package (Ahp) SoftwareSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on330descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −7 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −6 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −5 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −4 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −3 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −2 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −1 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| 0 (this device) | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +1 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| +2 | 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 | — |
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 | 3 | 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? (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 |
|---|---|---|---|
| * | K050034 | Sonoline Antares Diagnostic Ultrasound SystemSummary page 1…Product Code 90-4YO Diagnostic Ultrasound Transducer FR # 892.1570 Product Code 90-ITX 3. Predicate Device: * K050034, Antares Diagnostic Ultrasound System K052894. Sonoline G60 S Diagnostic Ultrasound System K… | 2005 |
| * | K052894 | Sonoline G60 S Ultrasound SystemSummary page 1…cer FR # 892.1570 Product Code 90-ITX 3. Predicate Device: * K050034, Antares Diagnostic Ultrasound System K052894. Sonoline G60 S Diagnostic Ultrasound System K * K043016, Sonoline Orchid Diagnostic Ultrasound… | 2005 |
| * | K043016 | Sonoline Orchid Diagnostic Ultrasound SystemSummary page 1…* K050034, Antares Diagnostic Ultrasound System K052894. Sonoline G60 S Diagnostic Ultrasound System K * K043016, Sonoline Orchid Diagnostic Ultrasound System K042044, Acuson CV70 Cardiovascular System K… | 2004 |
| * | K042044 | Acuson CV70 Cardiovascular SystemSummary page 1…K052894. Sonoline G60 S Diagnostic Ultrasound System K * K043016, Sonoline Orchid Diagnostic Ultrasound System K042044, Acuson CV70 Cardiovascular System K 4. Device Description: The Siemens Acuson X300 is a… | 2004 |
What descends from it? (428)
See all 4286 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071036 | Modification to Acuson X300 Ultrasound System | 2007 | 427 |
| K072676 | Acuson X300 Ultrasound System | 2007 | 279 |
| K080760 | Acuson X300 Ultrasound System | 2008 | 278 |
| K090276 | Acuson X300 Diagnostic Ultrasound System | 2009 | 277 |
| K093531 | Acuson Model X300 Diagnostic Ultrasound System | 2009 | 99 |
| K141720 | iuStar300 Medical Ultrasound Diagnostic System | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 19, 2008 | Not classified | Z-0086-2009 | Software design | Incorrect value calculations by the device may result in inaccurate aortic stenosis estimates. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 11 of the 38 ancestors have a recall of any class.
- Of its descendants, K071036 (Siemens Medical Solutions USA, Inc., Ultrasound DI, 2007) has gone furthest, with 427 descendants of its own.
- 5 other devices also cite its predicate K050034.
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.
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:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061946 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061946: Acuson X300 Diagnostic 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/K061946
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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