510(k) · Cleared
ClearedAcuson 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. · DQO Catheter, Intravascular, Diagnostic
Cleared on Feb 19, 2009 as substantially equivalent to K080760 (Siemens Medical Solutions USA, Inc., Ultrasound DI, 2008) and 6 other predicates after a 15-day review. Its family tree reaches back 12 generations to 1995. 277 later devices descend from it.
- Decided
- Feb 19, 2009
- Review
- 15 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 12 generations to K935595 (1995). 51 ancestors in all, the oldest K921148 (1992). 277 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 8 generations between
- 3 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 2 generations backK072676 Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 1 generation backK080760 Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008
- This deviceK090276 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2009
- Descendant · cites it directly · 176 of its ownK092691 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- Descendant · 2 generations on · 138 of its ownK100830 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- Descendant · 2 generations on · 130 of its ownK101041 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- Descendant · 3 generations on · 128 of its ownK102991 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- Descendant · 3 generations on · 123 of its ownK103677 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2011
Show all 12 generations
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 10 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 9 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 8 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 7 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 6 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 5 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 4 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 3 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 2 generations backK072676 Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 1 generation backK080760 Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008
- This deviceK090276 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2009
Showing 5 of 277 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 277 · See all- K092691DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009 · cites it directly176descendants
- K100830M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010 · 2 generations on138descendants
- K101041DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010 · 2 generations on130descendants
- K102991M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010 · 3 generations on128descendants
- K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2011 · 3 generations on123descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −11 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −10 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −9 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −8 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −7 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −6 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −5 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −4 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| −3 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −2 | 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 | — |
| 0 (this device) | K090276 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +1 | K092691 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| +2 | K100830 | M7/M7T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| +2 | K101041 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| +3 | K102991 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| +3 | K103677 | M7/M7T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2011 | — |
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 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 8 | 0 |
| 2012 | 9 | 0 |
| 2013 | 13 | 0 |
| 2014 | 9 | 0 |
| 2015 | 20 | 0 |
| 2016 | 15 | 0 |
| 2017 | 33 | 0 |
| 2018 | 17 | 0 |
| 2019 | 17 | 0 |
| 2020 | 23 | 0 |
| 2021 | 17 | 0 |
| 2022 | 18 | 0 |
| 2023 | 15 | 0 |
| 2024 | 22 | 0 |
| 2025 | 22 | 0 |
| 2026 | 11 | 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 DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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 |
|---|---|---|---|
| * | K080760 | Acuson X300 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 (K080760, K072676, K071036 and K061946) and the following: * K050240, ACUSON CV70 Cardiovascular System * K063085, ACUSON Sequoia… | 2008 |
| * | 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 (K080760, K072676, K071036 and K061946) and the following: * K050240, ACUSON CV70 Cardiovascular System * K063085, ACUSON Sequoia Ultrasoun… | 2007 |
| * | K071036 | Modification to Acuson X300 Ultrasound SystemSummary page 1…nd system with accessories and proprietary software, and is substantially equivalent to our current product, the Siemens Acuson X300 ultrasound system (K080760, K072676, K071036 and K061946) and the following: * K050240, ACUSON CV70 Cardiovascular System * K063085, ACUSON Sequoia Ultrasound System… | 2007 |
| * | K061946 | Acuson X300 Diagnostic Ultrasound SystemSummary page 1…th accessories and proprietary software, and is substantially equivalent to our current product, the Siemens Acuson X300 ultrasound system (K080760, K072676, K071036 and K061946) and the following: * K050240, ACUSON CV70 Cardiovascular System * K063085, ACUSON Sequoia Ultrasound System * K07103… | 2006 |
| * | K050240 | Modification to Acuson CV70 Cardiovascular SystemSummary page 1…tware, and is substantially equivalent to our current product, the Siemens Acuson X300 ultrasound system (K080760, K072676, K071036 and K061946) and the following: * K050240, ACUSON CV70 Cardiovascular System * K063085, ACUSON Sequoia Ultrasound System * K071036, Acuson X300 Diagnostic Ultrasou… | 2005 |
| * | K063085 | Modification to Acuson Sequoia Ultrasound SystemSummary page 1…rent product, the Siemens Acuson X300 ultrasound system (K080760, K072676, K071036 and K061946) and the following: * K050240, ACUSON CV70 Cardiovascular System * K063085, ACUSON Sequoia Ultrasound System * K071036, Acuson X300 Diagnostic Ultrasound System * K080760, ACUSON X300TM Diagnostic… | 2006 |
| * | K083149 | Arterial Health Package (Ahp) SoftwareSummary page 1…CUSON Sequoia Ultrasound System * K071036, Acuson X300 Diagnostic Ultrasound System * K080760, ACUSON X300TM Diagnostic Ultrasound System, premiunm edition · K083149, Arterial Health Package (AHP) software B. Device Description: The Acuson X300 has been designed to meet the following product s… | 2009 |
What descends from it? (277)
See all 2773 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 companies; a new generation was cleared every 10 months on median.
- 14 of the 51 ancestors have a recall of any class.
- Of its descendants, K092691 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2009) has gone furthest, with 176 descendants of its own.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
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 meas'ement of.anatomical structuresand-for analysis. packages that…
Read the full statement (160 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 meas'ement of.anatomical structuresand-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/K090276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090276: Acuson 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/K090276
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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