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 Mar 17, 2025 as substantially equivalent to K240553 (Dia Imaging Analysis, Ltd., 2024) after a 91-day review. Its family tree reaches back 18 generations to 1995.
- Decided
- Mar 17, 2025
- Review
- 91 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K935595 (1995). 115 ancestors in all, the oldest K894632 (1989). No later device cites it as a predicate yet.
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations between
- 3 generations backK210053 LVivo Software ApplicationDia Imaging Analysis, Ltd. · 2021
- 2 generations backK222970 LVivo IQSDia Imaging Analysis, Ltd. · 2023
- 1 generation backK240553 LVivo Software ApplicationDia Imaging Analysis, Ltd. · 2024
- This deviceK243862 LVivo Software ApplicationDia Imaging Analysis, Ltd. · 2025
Show all 18 generations
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 17 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 16 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 15 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 14 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 13 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 12 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 11 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 10 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 9 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 8 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 7 generations backK090461 Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis…Tomtec Imaging Systems GmbH · 2009 · Recalled
- 6 generations backK103782 4D MV-Assessment 2.0Tomtec Imaging Systems GmbH · 2011
- 5 generations backK132544 Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH · 2013
- 4 generations backK200232 LVivo Software ApplicationDia Imaging Analysis, Ltd. · 2020
- 3 generations backK210053 LVivo Software ApplicationDia Imaging Analysis, Ltd. · 2021
- 2 generations backK222970 LVivo IQSDia Imaging Analysis, Ltd. · 2023
- 1 generation backK240553 LVivo Software ApplicationDia Imaging Analysis, Ltd. · 2024
- This deviceK243862 LVivo Software ApplicationDia Imaging Analysis, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −17 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −16 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −15 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −14 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −13 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −12 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −11 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −10 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| −9 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −8 | K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −7 | K090461 | Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0 | Tomtec Imaging Systems GmbH | 2009 | 1 |
| −6 | K103782 | 4D MV-Assessment 2.0 | Tomtec Imaging Systems GmbH | 2011 | — |
| −5 | K132544 | Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-Arena | Tomtec Imaging Systems GmbH | 2013 | — |
| −4 | K200232 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2020 | — |
| −3 | K210053 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2021 | — |
| −2 | K222970 | LVivo IQS | Dia Imaging Analysis, Ltd. | 2023 | — |
| −1 | K240553 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2024 | — |
| 0 (this device) | K243862 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2025 | — |
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 |
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 23.5 · 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 |
|---|---|---|---|
| * | K240553 | LVivo Software ApplicationSummary page 5…Class 2 QIH, Regulation Number 21 CFR 892.2050 Name: LVivo Software Application 3. Predicate Devices: LVivo Software Application K240553 4. Description: The LVivo platform is a software system for automated analysis of… | 2024 |
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 30 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 19 of the 115 ancestors have a recall of any class.
- 1 other device also cites its predicate K240553.
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. 2025, 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 and Age >18. In addition, it has the ability to provide Quality Score feedback.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243862: 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/K243862
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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