510(k) · Cleared
ClearedLVivo Software Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dia Imaging Analysis, Ltd. · QIH Automated Radiological Image Processing Software
Cleared on Jun 23, 2020 as substantially equivalent to K132544 (Tomtec Imaging Systems GmbH, 2013) after a 145-day review. Its family tree reaches back 14 generations to 1995. 19 later devices descend from it.
- Decided
- Jun 23, 2020
- Review
- 145 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K935595 (1995). 111 ancestors in all, the oldest K894632 (1989). 19 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 10 generations between
- 3 generations backK090461 Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis…Tomtec Imaging Systems GmbH · 2009 · Recalled
- 2 generations backK103782 4D MV-Assessment 2.0Tomtec Imaging Systems GmbH · 2011
- 1 generation backK132544 Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH · 2013
- This deviceK200232 LVivo Software ApplicationDia Imaging Analysis, Ltd. · 2020
- Descendant · cites it directly · 11 of its ownK210053 LVivo Software ApplicationDia Imaging Analysis, Ltd. · 2021
- Descendant · 2 generations on · 6 of its ownK222970 LVivo IQSDia Imaging Analysis, Ltd. · 2023
- Descendant · cites it directly · 3 of its ownK222406 Clarius AIClarius Mobile Health Corp. · 2023
- Descendant · 3 generations on · 2 of its ownK240553 LVivo Software ApplicationDia Imaging Analysis, Ltd. · 2024
- Descendant · cites it directly · 2 of its ownK202546 LVivo SeamlessDia Imaging Analysis, Ltd. · 2020
Show all 14 generations
- Root · 14 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 13 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 12 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 11 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 10 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 9 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 8 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 7 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 6 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 5 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 4 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 3 generations backK090461 Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis…Tomtec Imaging Systems GmbH · 2009 · Recalled
- 2 generations backK103782 4D MV-Assessment 2.0Tomtec Imaging Systems GmbH · 2011
- 1 generation backK132544 Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH · 2013
- This deviceK200232 LVivo Software ApplicationDia Imaging Analysis, Ltd. · 2020
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K210053LVivo Software ApplicationDia Imaging Analysis, Ltd. · 2021 · cites it directly11descendants
- K222970LVivo IQSDia Imaging Analysis, Ltd. · 2023 · 2 generations on6descendants
- K222406Clarius AIClarius Mobile Health Corp. · 2023 · cites it directly3descendants
- K240553LVivo Software ApplicationDia Imaging Analysis, Ltd. · 2024 · 3 generations on2descendants
- K202546LVivo SeamlessDia Imaging Analysis, Ltd. · 2020 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −13 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −12 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −11 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −10 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −9 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −8 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −7 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −6 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| −5 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −4 | K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −3 | K090461 | Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0 | Tomtec Imaging Systems GmbH | 2009 | 1 |
| −2 | K103782 | 4D MV-Assessment 2.0 | Tomtec Imaging Systems GmbH | 2011 | — |
| −1 | K132544 | Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-Arena | Tomtec Imaging Systems GmbH | 2013 | — |
| 0 (this device) | K200232 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2020 | — |
| +1 | K210053 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2021 | — |
| +2 | K222970 | LVivo IQS | Dia Imaging Analysis, Ltd. | 2023 | — |
| +1 | K222406 | Clarius AI | Clarius Mobile Health Corp. | 2023 | — |
| +3 | K240553 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2024 | — |
| +1 | K202546 | LVivo Seamless | Dia Imaging Analysis, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 8 | 0 |
| 1996 | 5 | 0 |
| 1997 | 8 | 0 |
| 1998 | 3 | 0 |
| 1999 | 10 | 0 |
| 2000 | 7 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 11 | 0 |
| 2005 | 4 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 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 |
|---|---|---|---|
| * | K132544 | Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaSummary page 4…as Class 2 Classification QIH, Regulation Number 21 CFR 892.2050 Name: LVivo Software Application 3. Predicate Device: K132544 TomTec-Arena for RV Evaluation Reference K161382 & K130779- DiaCardio’s LVivo Software Application… | 2013 |
| † | K161382 | LVivo Software Application | 2016 |
| † | K130779 | Lvivo EF System | 2013 |
| † | K180995 | Vscan Extend | 2018 |
What descends from it? (19)
See all 193 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 25 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 19 of the 111 ancestors have a recall of any class.
- Of its descendants, K210053 (Dia Imaging Analysis, Ltd., 2021) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K132544.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200232 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200232: LVivo Software Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200232
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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