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 Jul 18, 2003 as substantially equivalent to K020353 (Siemens Medical Systems, Inc., 2002) and 1 other predicate after a 9-day review. Its family tree reaches back 3 generations to 1995. 2 of the 971 devices in its family, counting itself, have a Class I recall. 955 later devices descend from it. It has been recalled once.
- Decided
- Jul 18, 2003
- Review
- 9 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K935595 (1995). 15 ancestors in all, the oldest K921148 (1992). 955 later devices descend from it, 4 citing it directly. 2 of the 971 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 2 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 1 generation backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- This deviceK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003
- Descendant · cites it directly · 950 of its ownK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- Descendant · cites it directly · 932 of its ownK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 927 of its ownK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 927 of its ownK043016 Sonoline Orchid Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- Descendant · 2 generations on · 926 of its ownK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
Showing 5 of 955 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 955 · See all- K040060Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004 · cites it directly950descendants
- K042770Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · cites it directly932descendants
- K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · 2 generations on927descendants
- K043016Sonoline Orchid Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · 2 generations on927descendants
- K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 2 generations on926descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −2 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −1 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| 0 (this device) | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +1 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +1 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| +2 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| +2 | K043016 | Sonoline Orchid Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +2 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
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 |
|---|---|---|
| 2004 | 5 | 0 |
| 2005 | 8 | 0 |
| 2006 | 7 | 0 |
| 2007 | 10 | 0 |
| 2008 | 9 | 0 |
| 2009 | 14 | 0 |
| 2010 | 18 | 0 |
| 2011 | 26 | 0 |
| 2012 | 32 | 0 |
| 2013 | 41 | 0 |
| 2014 | 45 | 0 |
| 2015 | 53 | 0 |
| 2016 | 59 | 0 |
| 2017 | 76 | 0 |
| 2018 | 65 | 0 |
| 2019 | 49 | 0 |
| 2020 | 73 | 0 |
| 2021 | 53 | 0 |
| 2022 | 57 | 0 |
| 2023 | 57 | 0 |
| 2024 | 65 | 0 |
| 2025 | 79 | 2 |
| 2026 | 54 | 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.
2 devices in this family have a Class I recall. 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? (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 |
|---|---|---|---|
| * | K020353 | Omnia X/XS Ultrasound SystemSummary page 1…Product Code 90-IYO Diagnostic Ultrasound Transducer FR # 892.1570 Product Code 90-ITX 3. Predicate Device: K020353,2/13/2002,cleared as the Omnia XIXS, marketed as the SONOLINE G50 and SONOLINE G60 S. K022567. 8/13/200… | 2002 |
| * | K022567 | Sequoia Signature II Diagnostic Ultrasound SystemSummary page 1…-ITX 3. Predicate Device: K020353,2/13/2002,cleared as the Omnia XIXS, marketed as the SONOLINE G50 and SONOLINE G60 S. K022567. 8/13/2002, cleared as Sequoia Signature II 4. Device Descrlptlon: The CV70 is a general purpose, mobil… | 2002 |
What descends from it? (955)
See all 9554 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K040060 (Siemens Medical Solutions USA, Inc., 2004) has gone furthest, with 950 descendants of its own.
- 8 other devices also cite its predicate K020353.
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 ultrasound imaging system is intended for the following applications: Abdominal. Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesoptwgeal. Pelvic, NeonataIIAdult Cephalic, 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/K032111 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032111: Acuson CV70 Cardiovascular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032111
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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