510(k) · Cleared
Recalled · 2010Acuson 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. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Dec 18, 2007 as substantially equivalent to K071036 (Siemens Medical Solutions USA, Inc., Ultrasound DI, 2007) and 1 other predicate after an 88-day review. Its family tree reaches back 10 generations to 1995. 279 later devices descend from it. It has been recalled 5 times.
- Decided
- Dec 18, 2007
- Review
- 88 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 10 generations to K935595 (1995). 40 ancestors in all, the oldest K921148 (1992). 279 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 6 generations between
- 3 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 2 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 1 generation backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- This deviceK072676 Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 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 · 2 generations on · 176 of its ownK092691 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- Descendant · 3 generations on · 138 of its ownK100830 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- Descendant · 3 generations on · 130 of its ownK101041 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
Show all 10 generations
- Root · 10 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 9 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 8 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 7 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 6 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 5 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 4 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 3 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 2 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 1 generation backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- This deviceK072676 Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
Showing 5 of 279 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 279 · See all- 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
- K092691DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009 · 2 generations on176descendants
- K100830M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010 · 3 generations on138descendants
- K101041DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010 · 3 generations on130descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −9 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −8 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −7 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −6 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −5 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −4 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −3 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −2 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| −1 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| 0 (this device) | K072676 | Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +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 | — |
| +2 | K092691 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| +3 | K100830 | M7/M7T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| +3 | K101041 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K071036 | Modification to Acuson X300 Ultrasound SystemSummary page 6…pecify) P P P P P P BMDC Note 2,3,7,8,9,10 N = new indication; P = previously cleared by K071036; E = added under Appendix E Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic im… | 2007 |
| * | K061946 | Acuson X300 Diagnostic 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 (K(071036, K061946). B. Device Description: The Siemens Acuson X300 has been designed to meet the following product safety standards:… | 2006 |
What descends from it? (279)
See all 2793 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 17, 2010 | Not classified | Z-1838-2011 | Software change control | There is an error in the estimation of mean pressure gradient in the Cardiac measurement package. The currently implemented calculation will result in an underestimation of the mean pressure gradient (PGmean) when estimated from a trace… |
| Jul 30, 2009 | Not classified | Z-2065-2011 | Software design | Software Error with potential for misinterpretation of data-- The previous patient's last capture clip image can appear in the next patient's study. |
| Jul 24, 2009 | Not classified | Z-2061-2011 | Software design | Product Failure-- When the 64-Channel System V5M is used in the 128-Channel mode, an over current fault occurs which shuts the system down. |
| Jul 24, 2009 | Not classified | Z-2147-2011 | Software design | Mistreatment risk-- when a user defined formula is used to calculate a value in a vascular exam, data is switched laterally when it is internally transferred and displayed on the summary report within the system. |
| Aug 19, 2008 | Not classified | Z-0111-2009 | Employee error | Thermal Index cranial (TIC) is not displayed for the Neo-Head exam type with the C8-5 transducer. This is a required display to support the alara principle when imaging cranial structure. |
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 40 ancestors have a recall of any class.
- Of its descendants, K080760 (Siemens Medical Solutions USA, Inc., Ultrasound DI, 2008) has gone furthest, with 278 descendants of its own.
- 5 other devices also cite its predicate K071036.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 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 provide information that is used for clinical diagnosis purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072676 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072676: Acuson X300 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/K072676
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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