510(k) · Cleared
Recalled · 2008Acuson CV70 Cardiovascular 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 Aug 13, 2004 as substantially equivalent to K032111 (Siemens Medical Solutions USA, Inc., 2003) after a 14-day review. Its family tree reaches back 4 generations to 1995. 429 later devices descend from it. It has been recalled once.
- Decided
- Aug 13, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K935595 (1995). 16 ancestors in all, the oldest K921148 (1992). 429 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 3 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 2 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 1 generation backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- This deviceK042044 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004
- Descendant · cites it directly · 428 of its ownK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 427 of its ownK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- Descendant · 3 generations on · 330 of its ownK083149 Arterial Health Package (Ahp) SoftwareSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 279 of its ownK072676 Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 278 of its ownK080760 Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008
Showing 5 of 429 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 429 · See all- K061946Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · cites it directly428descendants
- K071036Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · 2 generations on427descendants
- K083149Arterial Health Package (Ahp) SoftwareSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on330descendants
- K072676Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · 2 generations on279descendants
- K080760Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008 · 2 generations on278descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −3 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −2 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −1 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| 0 (this device) | K042044 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +1 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| +2 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| +3 | K083149 | Arterial Health Package (Ahp) Software | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K032111 | Acuson CV70 Cardiovascular SystemSummary page 1…892.1560 90-IYO Diagnostic Ultrasound Transducer 892.1570 90-ITX Predicate Devices: · # K0321 11 (July 18, 2003) cleared as ACUSON CV70TM Cardiovascular System. Device Description: The CV70 system is a multi-purpose diag… | 2003 |
What descends from it? (429)
See all 4291 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061946 | Acuson X300 Diagnostic Ultrasound System | 2006 | 428 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 4, 2008 | Not classified | Z-2212-2008 | Software design | System may either display incorrect mechanical and thermal index values, or fail to display them altogether. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 16 ancestors have a recall of any class.
- Of its descendants, K061946 (Siemens Medical Solutions USA, Inc., 2006) has gone furthest, with 428 descendants of its own.
- 3 other devices also cite its predicate K032111.
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?
The CV70 platform is intended for use in the following applications:
Abdominal, Intraoperative, Small Parts, Transcranial, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications, and intended uses as defined in the FDA guidance document.
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/K042044 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042044: Acuson CV70 Cardiovascular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042044
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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