510(k) · Cleared
ClearedLvivo EF System
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 Aug 15, 2013 as substantially equivalent to K072090 (Siemens Medical Solutions USA, Inc., Ultrasound DI, 2007) and 1 other predicate after a 147-day review. Its family tree reaches back 11 generations to 1995. 24 later devices descend from it.
- Decided
- Aug 15, 2013
- Review
- 147 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K935595 (1995). 49 ancestors in all, the oldest K921148 (1992). 24 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 7 generations between
- 3 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 1 generation backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- This deviceK130779 Lvivo EF SystemDiacardio, Ltd. · 2013
- Descendant · cites it directly · 10 of its ownK180995 Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · Recalled
- Descendant · cites it directly · 10 of its ownK173780 EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK210791 Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai · 2021
- Descendant · 2 generations on · 3 of its ownK202035 Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020
- Descendant · 2 generations on · 3 of its ownK200621 Caption Interpretation Automated Ejection Fraction SoftwareCaption Health · 2020 · Recalled
Show all 11 generations
- Root · 11 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 10 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 9 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 8 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 7 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 6 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 5 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 4 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 3 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 1 generation backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- This deviceK130779 Lvivo EF SystemDiacardio, Ltd. · 2013
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · cites it directly10descendants
- K173780EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc. · 2018 · cites it directly10descendants
- K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai · 2021 · 2 generations on3descendants
- K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020 · 2 generations on3descendants
- K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health · 2020 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −10 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −9 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −8 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −7 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −6 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −5 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −4 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −3 | 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 | — |
| −1 | K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| 0 (this device) | K130779 | Lvivo EF System | Diacardio, Ltd. | 2013 | — |
| +1 | K180995 | Vscan Extend | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | 7 |
| +1 | K173780 | EchoMD Automated Ejection Fraction Software | Bay Labs, Inc. | 2018 | — |
| +2 | K210791 | Us2.v1 | Eko.Ai Pte Ltd. D/B/A Us2.Ai | 2021 | — |
| +2 | K202035 | Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | — |
| +2 | K200621 | Caption Interpretation Automated Ejection Fraction Software | Caption Health | 2020 | 1 |
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 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K072090 | Siemens Diagnostic Ultrasound SystemsSummary page 1…as Class 2 LLZ, Regulation Number 21 Classification CFR 892.2050 Name: LVivo EF Software Application 3. Predicate Devices: K072090- Siemens Medical Solution SYNGO Auto Left Heart and WL Clinical Feature… | 2007 |
| * | K070792 | Qlab QuantificationSummary page 1…3. Predicate Devices: K072090- Siemens Medical Solution SYNGO Auto Left Heart and WL Clinical Feature K070792- Philips Ultrasound, Inc. QLAB 20 Cardiac Quantification Plug-In 4. Description: The LVivoEF System analyzes echoc… | 2007 |
What descends from it? (24)
See all 244 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 18 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 12 of the 49 ancestors have a recall of any class.
- Of its descendants, K180995 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2018) has gone furthest, with 10 descendants of its own.
- 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. 2013, 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 EF 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/K130779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130779: Lvivo EF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130779
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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