510(k) · Cleared
ClearedImage-Arena Applications, Model Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, 4D LV-Analysis MR 1.0
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 Oct 1, 2008 as substantially equivalent to K071232 (Tomtec Imaging Systems GmbH, 2007) and 1 other predicate after a 33-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Oct 1, 2008
- Review
- 33 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K935595 (1995). 22 ancestors in all, the oldest K921148 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 5 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 4 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 3 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 2 generations backK040546 Image-Arena and Research-Arena ApplicationsTomtec Imaging Systems GmbH · 2004
- 1 generation backK071232 Image-Arena Applications and Research-Arena ApplicationsTomtec Imaging Systems GmbH · 2007
- This deviceK082510 Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D…Tomtec Imaging Systems GmbH · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −5 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −4 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −3 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −2 | K040546 | Image-Arena and Research-Arena Applications | Tomtec Imaging Systems GmbH | 2004 | — |
| −1 | K071232 | Image-Arena Applications and Research-Arena Applications | Tomtec Imaging Systems GmbH | 2007 | — |
| 0 (this device) | K082510 | Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D LV-Analysis… | Tomtec Imaging Systems GmbH | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 5 | 0 |
| 2000 | 4 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K071232 | Image-Arena Applications and Research-Arena ApplicationsSummary page 2…page 1 of 5 IMAG ING SYSTEMS Predicate Device TomTec K071232 Image-Arena Applications Research- Arena Applications… | 2007 |
| * | K041682 | Caas MRVSummary page 2…Tec K071232 Image-Arena Applications Research- Arena Applications K 041682 GAAS MRV Device Description The hardware requirements are based on an Intel Pentium high performance computer system… | 2004 |
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 13 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 22 ancestors have a recall of any class.
- 7 other devices also cite its predicate K071232.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 VA Platform software is intended to serve as a data management platform for clinical application packages.
As the Image-Arena Applications software tool package is modular structured, the clinical application packages are indicated as software packages for the ventricular analysis of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082510: Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, 4D LV-Analysis MR 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082510
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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