510(k) · Cleared
ClearedImage-Arena 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 Apr 27, 2004 as substantially equivalent to K022824 (Tomtec Imaging Systems GmbH, 2002) and 3 other predicates after a 56-day review. Its family tree reaches back 4 generations to 1995. 184 later devices descend from it.
- Decided
- Apr 27, 2004
- Review
- 56 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K935595 (1995). 16 ancestors in all, the oldest K921148 (1992). 184 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 3 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 2 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 1 generation backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- This deviceK040546 Image-Arena and Research-Arena ApplicationsTomtec Imaging Systems GmbH · 2004
- Descendant · cites it directly · 97 of its ownK060992 Syngo US WorkplaceSiemens Medical Solutions · 2006 · Recalled
- Descendant · 2 generations on · 95 of its ownK091286 Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009
- Descendant · cites it directly · 94 of its ownK071232 Image-Arena Applications and Research-Arena ApplicationsTomtec Imaging Systems GmbH · 2007
- Descendant · 3 generations on · 92 of its ownK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
- Descendant · 4 generations on · 91 of its ownK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · Recalled
Showing 5 of 184 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 184 · See all- K060992Syngo US WorkplaceSiemens Medical Solutions · 2006 · cites it directly97descendants
- K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on95descendants
- K071232Image-Arena Applications and Research-Arena ApplicationsTomtec Imaging Systems GmbH · 2007 · cites it directly94descendants
- K130159Qlab Quantification Software Heart ModelPhilips Health Care · 2013 · 3 generations on92descendants
- K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · 4 generations on91descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −3 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −2 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −1 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| 0 (this device) | K040546 | Image-Arena and Research-Arena Applications | Tomtec Imaging Systems GmbH | 2004 | — |
| +1 | K060992 | Syngo US Workplace | Siemens Medical Solutions | 2006 | 1 |
| +2 | K091286 | Syngo US Workplace | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +1 | K071232 | Image-Arena Applications and Research-Arena Applications | Tomtec Imaging Systems GmbH | 2007 | — |
| +3 | K130159 | Qlab Quantification Software Heart Model | Philips Health Care | 2013 | — |
| +4 | K132165 | Qlab Quantification Software | Philips Ultrasound, Inc. | 2013 | 1 |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 7 | 0 |
| 2019 | 8 | 0 |
| 2020 | 21 | 0 |
| 2021 | 12 | 0 |
| 2022 | 18 | 0 |
| 2023 | 16 | 0 |
| 2024 | 19 | 0 |
| 2025 | 30 | 0 |
| 2026 | 19 | 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? (4)
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 |
|---|---|---|---|
| * | K022824 | Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X & Surgical…Summary page 2…xius ACQ) Axius Edge Assisted Ejection Fraction (Axius Edge Assisted EF) Predicate Device TomTec Echo-View K022824 TomTec Echo-Com K001592 Siemens SequoiaTM Diagnostic Ultrasound System Signat… | 2002 |
| * | K001592 | Echocom, Imagecom, DokucomSummary page 2…e Assisted EF) Predicate Device TomTec Echo-View K022824 TomTec Echo-Com K001592 Siemens SequoiaTM Diagnostic Ultrasound System Signature II, Axius TM SW Applications… | 2000 |
| * | K022567 | Sequoia Signature II Diagnostic Ultrasound SystemSummary page 2…K001592 Siemens SequoiaTM Diagnostic Ultrasound System Signature II, Axius TM SW Applications K022567 Siemens SequoiaTM Diagnostic Ultrasound System AxiuS TM SW Applications K032114 D… | 2002 |
| * | K032114 | Sequoia 8.0 Diagnostic Ultrasound SystemSummary page 2…SW Applications K022567 Siemens SequoiaTM Diagnostic Ultrasound System AxiuS TM SW Applications K032114 Device Description The hardware requirements are based on an Intel Pentium high performance computer system and Microsoft® Win… | 2003 |
What descends from it? (184)
See all 1845 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 9 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K060992 (Siemens Medical Solutions, 2006) has gone furthest, with 97 descendants of its own.
- 3 other devices also cite its predicate K022824.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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/Research-Arena Applications software tool package is intended to acquire, store, retrieve, analyze and report digital ultrasound studies. The Image-Arena Platform and the Research-Arena Platform are based on a SQL - database intended as image management system especially for medical ultrasound studies. The Image-Arena/Research-Arena Applications software can import certain digital 2D or 3D image file formats for 2D/3D and 4D tomographic…
Read the full statement (118 words)
The Image-Arena/Research-Arena Applications software tool package is intended to acquire, store, retrieve, analyze and report digital ultrasound studies. The Image-Arena Platform and the Research-Arena Platform are based on a SQL - database intended as image management system especially for medical ultrasound studies.
The Image-Arena/Research-Arena Applications software can import certain digital 2D or 3D image file formats for 2D/3D and 4D tomographic reconstructions and surface rendering.
The software is suited to stand-alone workstations as well as networked multi-system installations and is therefore an image management system for research and routine use in both physician practices and hospitals. It is intended as a general purpose digital medical image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040546 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040546: Image-Arena and Research-Arena Applications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040546
Report an extraction error
Are you the manufacturer?
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