510(k) · Cleared
ClearedImage-Arena Applications and Research-Arena Applications
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tomtec Imaging Systems GmbH · LLZ System, Image Processing, Radiological
Cleared on Jun 20, 2007 as substantially equivalent to K040546 (Tomtec Imaging Systems GmbH, 2004) after a 48-day review. Its family tree reaches back 5 generations to 1995. 94 later devices descend from it.
- Decided
- Jun 20, 2007
- Review
- 48 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K935595 (1995). 17 ancestors in all, the oldest K921148 (1992). 94 later devices descend from it, 8 citing it directly.
- Root · 5 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 4 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 3 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 2 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 1 generation backK040546 Image-Arena and Research-Arena ApplicationsTomtec Imaging Systems GmbH · 2004
- This deviceK071232 Image-Arena Applications and Research-Arena ApplicationsTomtec Imaging Systems GmbH · 2007
- Descendant · cites it directly · 89 of its ownK083348 Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2008
- Descendant · 2 generations on · 86 of its ownK090461 Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis…Tomtec Imaging Systems GmbH · 2009 · Recalled
- Descendant · 3 generations on · 82 of its ownK120135 2D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH · 2012
- Descendant · cites it directly · 82 of its ownK082596 Ultraextend Usws-900AToshiba America Medical Systems, In.C · 2008
- Descendant · cites it directly · 80 of its ownK110746 4D LV-Analysis 3.0Tomtec Imaging Systems GmbH · 2011
Showing 5 of 94 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 94 · See all- K083348Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2008 · cites it directly89descendants
- K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH · 2009 · 2 generations on86descendants
- K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH · 2012 · 3 generations on82descendants
- K082596Ultraextend Usws-900AToshiba America Medical Systems, In.C · 2008 · cites it directly82descendants
- K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH · 2011 · cites it directly80descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −4 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −3 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −2 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −1 | K040546 | Image-Arena and Research-Arena Applications | Tomtec Imaging Systems GmbH | 2004 | — |
| 0 (this device) | K071232 | Image-Arena Applications and Research-Arena Applications | Tomtec Imaging Systems GmbH | 2007 | — |
| +1 | K083348 | Image-Arena Applications | Tomtec Imaging Systems GmbH | 2008 | — |
| +2 | K090461 | Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0 | Tomtec Imaging Systems GmbH | 2009 | 1 |
| +3 | K120135 | 2D Cardiac Performance Analysis MR 1.0 | Tomtec Imaging Systems GmbH | 2012 | — |
| +1 | K082596 | Ultraextend Usws-900A | Toshiba America Medical Systems, In.C | 2008 | — |
| +1 | K110746 | 4D LV-Analysis 3.0 | Tomtec Imaging Systems GmbH | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 13 | 0 |
| 2021 | 5 | 0 |
| 2022 | 9 | 0 |
| 2023 | 10 | 0 |
| 2024 | 8 | 0 |
| 2025 | 17 | 0 |
| 2026 | 6 | 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? (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 |
|---|---|---|---|
| * | K040546 | Image-Arena and Research-Arena ApplicationsSummary page 2…0 0 1 3 page1 of 5 IMAGING 'SST EMS,~ Predicate Device TomTec K040546 Image-Arena Applications Research-Arena Applications Device Description The hardware requi… | 2004 |
What descends from it? (94)
See all 948 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083348 | Image-Arena Applications | 2008 | 89 |
| K082596 | Ultraextend Usws-900A | 2008 | 82 |
| K110746 | 4D LV-Analysis 3.0 | 2011 | 80 |
| K122289 | Image-Com 5.0 | 2012 | 79 |
| K110595 | 4D Sono-Scan 1.0 | 2011 | 79 |
| K103782 | 4D MV-Assessment 2.0 | 2011 | 79 |
| K132544 | Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-Arena | 2013 | 78 |
| K082510 | Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, 4D… | 2008 | 0 |
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 12 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K083348 (Tomtec Imaging Systems GmbH, 2008) has gone furthest, with 89 descendants of its own.
- 4 other devices also cite its predicate K040546.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The Image-Arena and Research-Arena Platform Software is intended to serve as a data management platform for clinical application packages.
As the Image-Arena and Research-Arena Applications software tool package is modular structured, the clinical applications packages are indicated as software packages for analysis of the left ventricle in heart failure patients, to analyze pathologies related to the Mitral Valve and for analysis of the right ventricle in all patients with a need of right heart function diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071232 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071232: Image-Arena Applications and Research-Arena Applications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071232
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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