510(k) · Cleared
ClearedAcuson Model X300 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medi Cal Solutions, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Dec 1, 2009 as substantially equivalent to K090276 (Siemens Medical Solutions USA, Inc., 2009) and 5 other predicates after a 15-day review. Its family tree reaches back 13 generations to 1995. 99 later devices descend from it.
- Decided
- Dec 1, 2009
- Review
- 15 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K935595 (1995). 54 ancestors in all, the oldest K921148 (1992). 99 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 9 generations between
- 3 generations backK072676 Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 2 generations backK080760 Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008
- 1 generation backK090276 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2009
- This deviceK093531 Acuson Model X300 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2009
- Descendant · cites it directly · 98 of its ownK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
- Descendant · 2 generations on · 96 of its ownK123622 AcusonSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 74 of its ownK123001 Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 73 of its ownK132804 Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · Recalled
- Descendant · 4 generations on · 60 of its ownK140959 Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014
Show all 13 generations
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 12 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 11 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 10 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 9 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 8 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 7 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 6 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 5 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 4 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 3 generations backK072676 Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 2 generations backK080760 Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008
- 1 generation backK090276 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2009
- This deviceK093531 Acuson Model X300 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2009
Showing 5 of 99 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 99 · See all- K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · cites it directly98descendants
- K123622AcusonSiemens Medical Solutions USA, Inc. · 2012 · 2 generations on96descendants
- K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · 2 generations on74descendants
- K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · 3 generations on73descendants
- K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014 · 4 generations on60descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −12 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −11 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −10 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −9 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −8 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −7 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −6 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −5 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| −4 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −3 | K072676 | Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | 5 |
| −2 | 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 | — |
| 0 (this device) | K093531 | Acuson Model X300 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2009 | — |
| +1 | K121699 | Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2012 | — |
| +2 | K123622 | Acuson | Siemens Medical Solutions USA, Inc. | 2012 | 13 |
| +2 | K123001 | Acuson X700 Diagnstic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2012 | 2 |
| +3 | K132804 | Acuson S1000 / S2000 / S3000 | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013 | 3 |
| +4 | K140959 | Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | — |
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 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 8 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 8 | 0 |
| 2018 | 6 | 0 |
| 2019 | 6 | 0 |
| 2020 | 11 | 0 |
| 2021 | 7 | 0 |
| 2022 | 9 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 9 | 0 |
| 2026 | 5 | 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? (6)
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 |
|---|---|---|---|
| * | K090276 | 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 (K090276, 1K072676, K(071036 and K061946) and the following: *K061980, Siemens Acuson X500Th Ultrasound System *K1081121, ACUSON… | 2009 |
| * | K072676 | Acuson X300 Ultrasound SystemSummary page 1…ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product, the Siemens Acuson X300 ultrasound system (K090276, 1K072676, K(071036 and K061946) and the following: *K061980, Siemens Acuson X500Th Ultrasound System *K1081121, ACUSON X150 Ultr… | 2007 |
| * | K071036 | Modification to Acuson X300 Ultrasound SystemSummary page 1…system with accessories and proprietary software, and is substantially equivalent to our current product, the Siemens Acuson X300 ultrasound system (K090276, 1K072676, K(071036 and K061946) and the following: *K061980, Siemens Acuson X500Th Ultrasound System *K1081121, ACUSON X150 Ultrasound Sys… | 2007 |
| * | K061946 | Acuson X300 Diagnostic Ultrasound SystemSummary page 1…accessories and proprietary software, and is substantially equivalent to our current product, the Siemens Acuson X300 ultrasound system (K090276, 1K072676, K(071036 and K061946) and the following: *K061980, Siemens Acuson X500Th Ultrasound System *K1081121, ACUSON X150 Ultrasound System *K1… | 2006 |
| * | K061980 | Siemens Acuson X500 Ultrasound SystemSummary page 1…are, and is substantially equivalent to our current product, the Siemens Acuson X300 ultrasound system (K090276, 1K072676, K(071036 and K061946) and the following: *K061980, Siemens Acuson X500Th Ultrasound System *K1081121, ACUSON X150 Ultrasound System *K1090276, ACUSON X3 00 TM Diagnostic… | 2006 |
| * | K081121 | Modification to Acuson X150 Ultrasound SystemSummary page 1…ct, the Siemens Acuson X300 ultrasound system (K090276, 1K072676, K(071036 and K061946) and the following: *K061980, Siemens Acuson X500Th Ultrasound System *K1081121, ACUSON X150 Ultrasound System *K1090276, ACUSON X3 00 TM Diagnostic Ultrasound System, Premium Edition B. Device Descripti… | 2008 |
What descends from it? (99)
See all 991 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121699 | Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound System | 2012 | 98 |
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 14 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 14 of the 54 ancestors have a recall of any class.
- Of its descendants, K121699 (Siemens Medical Solutions USA, Inc., 2012) has gone furthest, with 98 descendants of its own.
- 2 other devices also cite its predicate K090276.
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. 2009, 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 X300 ultrasound imaging system is intended for the following applications:
General Radiology, Fetal, Abdominal, Intraoiperative, Pediatric, Small Parts, Neonatal/Adult
Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular,
Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular 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.
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/K093531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093531: Acuson Model X300 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/K093531
Report an extraction error
Are you the manufacturer?
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