510(k) · Cleared
ClearedAcuson X300 Diagnostic Ultrasound System Sonovista 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 Jun 22, 2012 as substantially equivalent to K090276 (Siemens Medical Solutions USA, Inc., 2009) and 6 other predicates after a 14-day review. Its family tree reaches back 15 generations to 1995. 98 later devices descend from it.
- Decided
- Jun 22, 2012
- Review
- 14 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 15 generations to K935595 (1995). 137 ancestors in all, the oldest K863700 (1987). 98 later devices descend from it, 7 citing it directly.
- Root · 15 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations between
- 3 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 2 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 1 generation backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- This deviceK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
- Descendant · cites it directly · 96 of its ownK123622 AcusonSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- Descendant · cites it directly · 74 of its ownK123001 Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 73 of its ownK132804 Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · Recalled
- Descendant · 3 generations on · 60 of its ownK140959 Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014
- Descendant · 2 generations on · 58 of its ownK142876 ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014 · Recalled
Show all 15 generations
- Root · 15 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 13 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 12 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 11 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 10 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 9 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 8 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 7 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 6 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 5 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 4 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 3 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 2 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 1 generation backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- This deviceK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
Showing 5 of 98 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 98 · See all- K123622AcusonSiemens Medical Solutions USA, Inc. · 2012 · cites it directly96descendants
- K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · cites it directly74descendants
- K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · 2 generations on73descendants
- K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014 · 3 generations on60descendants
- K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014 · 2 generations on58descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −14 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −13 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −12 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −11 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −10 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −9 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −8 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −7 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −6 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −5 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −4 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −3 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −2 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −1 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| 0 (this device) | K121699 | Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2012 | — |
| +1 | K123622 | Acuson | Siemens Medical Solutions USA, Inc. | 2012 | 13 |
| +1 | K123001 | Acuson X700 Diagnstic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2012 | 2 |
| +2 | K132804 | Acuson S1000 / S2000 / S3000 | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013 | 3 |
| +3 | K140959 | Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | — |
| +2 | K142876 | ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 9 | 0 |
| 2002 | 9 | 0 |
| 2003 | 10 | 0 |
| 2004 | 15 | 0 |
| 2005 | 11 | 0 |
| 2006 | 8 | 0 |
| 2007 | 7 | 0 |
| 2008 | 8 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 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? (7)
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…SONOVISTA X300 Diagnostic Ultrasound System ACUSON X300' m Diagnostic Ultrasound System, premium edition (K090276, K093531) 11.5. Common Name: Diagnostic Ultrasound System with Accessories 11.6. Classification: Regulatory Class:… | 2009 |
| * | K093531 | Acuson Model X300 Diagnostic Ultrasound SystemSummary page 1…SONOVISTA X300 Diagnostic Ultrasound System ACUSON X300' m Diagnostic Ultrasound System, premium edition (K090276, K093531) 11.5. Common Name: Diagnostic Ultrasound System with Accessories 11.6. Classification: Regulatory Class: 11 Revie… | 2009 |
| * | K113179 | Acuson SC2000 Diagnostic Ultrasound SystemSummary page 1…0 Tm Diagnostic Ultrasound System, SONOVISTA X300 Diagnostic Ultrasound System, ACUSON X300TM Diagnostic Ultrasound System, premium edition * K1 131 79, ACUSON SC2000'M Diagnostic Ultrasound System * K101091, ZONARE zone Ultra Ultrasoud System * K1 13690, GE LOGIQ… | 2011 |
| * | K101091 | Z.One Ultra Ultrasound SystemSummary page 1…stic Ultrasound System, ACUSON X300TM Diagnostic Ultrasound System, premium edition * K1 131 79, ACUSON SC2000'M Diagnostic Ultrasound System * K101091, ZONARE zone Ultra Ultrasoud System * K1 13690, GE LOGIQ i, LOGIO e, Vivid e * K014206, GE LogiqBooK XP *… | 2010 |
| * | K113690 | GE Logiq I, Logiq E and Vivid ESummary page 1…sound System, premium edition * K1 131 79, ACUSON SC2000'M Diagnostic Ultrasound System * K101091, ZONARE zone Ultra Ultrasoud System * K1 13690, GE LOGIQ i, LOGIO e, Vivid e * K014206, GE LogiqBooK XP * K101 757, Sonosite M-turbo B. Device Description: T… | 2011 |
| * | K014206 | LogiqbookSummary page 1…K1 131 79, ACUSON SC2000'M Diagnostic Ultrasound System * K101091, ZONARE zone Ultra Ultrasoud System * K1 13690, GE LOGIQ i, LOGIO e, Vivid e * K014206, GE LogiqBooK XP * K101 757, Sonosite M-turbo B. Device Description: The Siemens ACUSON X300 Diagnostic Ultrasound Sys… | 2002 |
| * | K101757 | Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound SystemSummary page 1…tic Ultrasound System * K101091, ZONARE zone Ultra Ultrasoud System * K1 13690, GE LOGIQ i, LOGIO e, Vivid e * K014206, GE LogiqBooK XP * K101 757, Sonosite M-turbo B. Device Description: The Siemens ACUSON X300 Diagnostic Ultrasound System is a multi-purpose mobile, softw… | 2010 |
What descends from it? (98)
See all 987 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123622 | Acuson | 2012 | 96 |
| K123001 | Acuson X700 Diagnstic Ultrasound System | 2012 | 74 |
| K141846 | Acuson X700 Ultrasound System, Acuson X600 Ultrasound System | 2014 | 41 |
| K152469 | ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System | 2015 | 33 |
| K150050 | ACUSON P500 Diagnostic Ultrasound System | 2015 | 28 |
| K173957 | ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System | 2018 | 8 |
| K142395 | SC2000 and ACUSON X300 Diagnostic Ultrasound Systems | 2014 | 0 |
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 17 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 35 of the 137 ancestors have a recall of any class.
- Of its descendants, K123622 (Siemens Medical Solutions USA, Inc., 2012) has gone furthest, with 96 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. 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 X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, 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…
Read the full statement (163 words)
The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, 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.
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".
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121699 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121699: Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic 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/K121699
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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