510(k) · Cleared
ClearedImage-Arena and Image-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 8, 2011 as substantially equivalent to K083348 (Tomtec Imaging Systems GmbH, 2008) and 1 other predicate after a 30-day review. Its family tree reaches back 7 generations to 1995. 80 later devices descend from it.
- Decided
- Apr 8, 2011
- Review
- 30 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K935595 (1995). 29 ancestors in all, the oldest K921148 (1992). 80 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 6 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 5 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 4 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 3 generations backK040546 Image-Arena and Research-Arena ApplicationsTomtec Imaging Systems GmbH · 2004
- 2 generations backK071232 Image-Arena Applications and Research-Arena ApplicationsTomtec Imaging Systems GmbH · 2007
- 1 generation backK083348 Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2008
- This deviceK110667 Image-Arena and Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2011
- Descendant · cites it directly · 79 of its ownK122289 Image-Com 5.0Tomtec Imaging Systems GmbH · 2012
- Descendant · cites it directly · 78 of its ownK132544 Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH · 2013
- Descendant · cites it directly · 56 of its ownK150122 Tomtec-Arena TTA2Tomtec Imaging Systems GmbH · 2015 · Recalled
- Descendant · 2 generations on · 35 of its ownK170823 Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2017 · Recalled
- Descendant · 3 generations on · 20 of its ownK173341 Vivid E80, Vivid E90, Vivid E95GE Medical Systems · 2017 · Recalled
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 80 · See all- K122289Image-Com 5.0Tomtec Imaging Systems GmbH · 2012 · cites it directly79descendants
- K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH · 2013 · cites it directly78descendants
- K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH · 2015 · cites it directly56descendants
- K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2017 · 2 generations on35descendants
- K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems · 2017 · 3 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −6 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −5 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −4 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −3 | K040546 | Image-Arena and Research-Arena Applications | Tomtec Imaging Systems GmbH | 2004 | — |
| −2 | K071232 | Image-Arena Applications and Research-Arena Applications | Tomtec Imaging Systems GmbH | 2007 | — |
| −1 | K083348 | Image-Arena Applications | Tomtec Imaging Systems GmbH | 2008 | — |
| 0 (this device) | K110667 | Image-Arena and Image-Arena Applications | Tomtec Imaging Systems GmbH | 2011 | — |
| +1 | K122289 | Image-Com 5.0 | Tomtec Imaging Systems GmbH | 2012 | — |
| +1 | K132544 | Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-Arena | Tomtec Imaging Systems GmbH | 2013 | — |
| +1 | K150122 | Tomtec-Arena TTA2 | Tomtec Imaging Systems GmbH | 2015 | 1 |
| +2 | K170823 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2017 | 3 |
| +3 | K173341 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems | 2017 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 13 | 0 |
| 2021 | 5 | 0 |
| 2022 | 9 | 0 |
| 2023 | 9 | 0 |
| 2024 | 7 | 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? (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 |
|---|---|---|---|
| * | K083348 | Image-Arena ApplicationsSummary page 2…page 1 of 6 55 Predicate Devices Predicate Device 1 K083348 Image-Arena Platform 4.0, Server Manager 4.0, Echo-Corn 4.0,Image-… | 2008 |
| * | K061995 | XceleraSummary page 2…Manager 4.0, Echo-Corn 4.0,Image-Com _____________ _______4.0, TomTec Imaging Systems GmbH Predicate Device 2 K061995 Xcelera, Philips Medical Systems North ________ _ __ ____ America CO. Device Descrip… | 2006 |
What descends from it? (80)
See all 803 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 16 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 5 of the 29 ancestors have a recall of any class.
- Of its descendants, K122289 (Tomtec Imaging Systems GmbH, 2012) has gone furthest, with 79 descendants of its own.
- 1 other device also cites its predicate K083348.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Iniage-Arena software platform is intended to import, export, store; retrieve and report digital studies. The Image-Arena software is based on a SQL - database and is intended as an image management system. The Image-Arena software can import certain digital 2D or 3D image file formats of different modalities. Image-Arena offers a Generic Clinical Application Package interface in order to connect TomTec applications as well as commercially available…
Read the full statement (206 words)
The Iniage-Arena software platform is intended to import, export, store; retrieve and report digital studies. The Image-Arena software is based on a SQL - database and is intended as an image management system. The Image-Arena software can import certain digital 2D or 3D image file formats of different modalities.
Image-Arena offers a Generic Clinical Application Package interface in order to connect TomTec applications as well as commercially available analysis and quantification tools to the Image-Arena platform.
The software is suited for stand-alone workstations as well as for networked multi-system installations and therefore is an image management system for physician practices and hospitals. It is intended as a general purpose digital medical image processing tool.
Image-Arena is not intended to be used for reading of mammography images.
Image-Corn software is intended for reviewing, and measuring of digital medical data of different modalities. It can be driven by Image-Arena or other third party platforms and is intended to launch other commercially available analysis and quantification tools.
Echo-Corn software is intended to serve as a versatile solution for Stress echo examinations in patients who may not be receiving enough oxygen because of blocked arteries. Echo-Coin software is intended for reviewing, wall motion scoring and reporting of stress echo studies.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110667: Image-Arena and Image-Arena Applications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110667
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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