510(k) · Cleared
ClearedLVivo Software Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diacardio, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Jul 28, 2016 as substantially equivalent to K072090 (Siemens Medical Solutions USA, Inc., Ultrasound DI, 2007) and 2 other predicates after a 71-day review. Its family tree reaches back 12 generations to 1995.
- Decided
- Jul 28, 2016
- Review
- 71 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K935595 (1995). 69 ancestors in all, the oldest K891449 (1989). No later device cites it as a predicate yet.
- 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 backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 1 generation backK091286 Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009
- This deviceK161382 LVivo Software ApplicationDiacardio, Ltd. · 2016
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 backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 1 generation backK091286 Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009
- This deviceK161382 LVivo Software ApplicationDiacardio, Ltd. · 2016
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 | K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −1 | K091286 | Syngo US Workplace | Siemens Medical Solutions USA, Inc. | 2009 | — |
| 0 (this device) | K161382 | LVivo Software Application | Diacardio, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K072090 | Siemens Diagnostic Ultrasound SystemsSummary page 4…as Class 2 LLZ, Regulation Number 21 Classification CFR 892.2050 Name: LVivo Software Application 3. Predicate Devices: K072090- Siemens Medical Solution SYNGO Auto Left Heart and VVL Clinical Feature… | 2007 |
| * | K091286 | Syngo US WorkplaceSummary page 4…. Predicate Devices: K072090- Siemens Medical Solution SYNGO Auto Left Heart and VVL Clinical Feature K091286- Siemens Medical Solution SYNGO US Workplace K130779- DiaCardio’s LVivoEF Software Application 4.… | 2009 |
| * | K130779 | Lvivo EF SystemSummary page 4…t and VVL Clinical Feature K091286- Siemens Medical Solution SYNGO US Workplace K130779- DiaCardio’s LVivoEF Software Application 4. Description: The LVivo System analyzes echocar… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 15 of the 69 ancestors have a recall of any class.
- 4 other devices also cite its predicate K072090.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
DiaCardio’s LVivo Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement can be used to assist the clinician in a cardiac evaluation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161382: LVivo Software Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161382
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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