510(k) · Cleared
ClearedImage-Com 5.0
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 24, 2012 as substantially equivalent to K110667 (Tomtec Imaging Systems GmbH, 2011) and 1 other predicate after an 86-day review. Its family tree reaches back 8 generations to 1995. 79 later devices descend from it.
- Decided
- Oct 24, 2012
- Review
- 86 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K935595 (1995). 30 ancestors in all, the oldest K921148 (1992). 79 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 7 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 6 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 5 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 4 generations backK040546 Image-Arena and Research-Arena ApplicationsTomtec Imaging Systems GmbH · 2004
- 3 generations backK071232 Image-Arena Applications and Research-Arena ApplicationsTomtec Imaging Systems GmbH · 2007
- 2 generations backK083348 Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2008
- 1 generation backK110667 Image-Arena and Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2011
- This deviceK122289 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 · 2 generations on · 56 of its ownK150122 Tomtec-Arena TTA2Tomtec Imaging Systems GmbH · 2015 · Recalled
- Descendant · 3 generations on · 35 of its ownK170823 Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2017 · Recalled
- Descendant · 4 generations on · 20 of its ownK173341 Vivid E80, Vivid E90, Vivid E95GE Medical Systems · 2017 · Recalled
- Descendant · 2 generations on · 19 of its ownK200232 LVivo Software ApplicationDia Imaging Analysis, Ltd. · 2020
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 79 · See all- K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH · 2013 · cites it directly78descendants
- K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH · 2015 · 2 generations on56descendants
- K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2017 · 3 generations on35descendants
- K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems · 2017 · 4 generations on20descendants
- K200232LVivo Software ApplicationDia Imaging Analysis, Ltd. · 2020 · 2 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −7 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −6 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −5 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −4 | K040546 | Image-Arena and Research-Arena Applications | Tomtec Imaging Systems GmbH | 2004 | — |
| −3 | K071232 | Image-Arena Applications and Research-Arena Applications | Tomtec Imaging Systems GmbH | 2007 | — |
| −2 | K083348 | Image-Arena Applications | Tomtec Imaging Systems GmbH | 2008 | — |
| −1 | K110667 | Image-Arena and Image-Arena Applications | Tomtec Imaging Systems GmbH | 2011 | — |
| 0 (this device) | 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 | — |
| +2 | K150122 | Tomtec-Arena TTA2 | Tomtec Imaging Systems GmbH | 2015 | 1 |
| +3 | K170823 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2017 | 3 |
| +4 | K173341 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems | 2017 | 3 |
| +2 | K200232 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2020 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K110667 | Image-Arena and Image-Arena ApplicationsSummary page 1…cation Name: Picture archiving and communications system Proprietary Name(s): Image-Cam 5.0 Predicate Devices Predicate Device 1 K1 10667 Image-Arena Platform 4.5, Echo-Coin 4.5, Image-Corn 4.5 Predicate Device 2 K071232 Im… | 2011 |
| * | K071232 | Image-Arena Applications and Research-Arena ApplicationsSummary page 1…Cam 5.0 Predicate Devices Predicate Device 1 K1 10667 Image-Arena Platform 4.5, Echo-Coin 4.5, Image-Corn 4.5 Predicate Device 2 K071232 Image-Arena Applications; Research- Arena Applications : 40 Cardio-View 2.x summary… | 2007 |
What descends from it? (79)
See all 791 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132544 | Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-Arena | 2013 | 78 |
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 17 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 5 of the 30 ancestors have a recall of any class.
- Of its descendants, K132544 (Tomtec Imaging Systems GmbH, 2013) has gone furthest, with 78 descendants of its own.
- 2 other devices also cite its predicate K110667.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122289 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122289: Image-Com 5.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122289
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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