510(k) · Cleared
ClearedTomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-Arena
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 Nov 25, 2013 as substantially equivalent to K071232 (Tomtec Imaging Systems GmbH, 2007) and 7 other predicates after a 104-day review. Its family tree reaches back 13 generations to 1995. 78 later devices descend from it.
- Decided
- Nov 25, 2013
- Review
- 104 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 13 generations to K935595 (1995). 110 ancestors in all, the oldest K894632 (1989). 78 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 9 generations between
- 3 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 2 generations backK090461 Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis…Tomtec Imaging Systems GmbH · 2009 · Recalled
- 1 generation backK103782 4D MV-Assessment 2.0Tomtec Imaging Systems GmbH · 2011
- This deviceK132544 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
- Descendant · cites it directly · 19 of its ownK200232 LVivo Software ApplicationDia Imaging Analysis, Ltd. · 2020
- Descendant · 4 generations on · 13 of its ownK181685 Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
Show all 13 generations
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 12 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 11 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 10 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 9 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 8 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 7 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 6 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 5 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 4 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 3 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 2 generations backK090461 Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis…Tomtec Imaging Systems GmbH · 2009 · Recalled
- 1 generation backK103782 4D MV-Assessment 2.0Tomtec Imaging Systems GmbH · 2011
- This deviceK132544 Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH · 2013
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- 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
- K200232LVivo Software ApplicationDia Imaging Analysis, Ltd. · 2020 · cites it directly19descendants
- K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −12 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −11 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −10 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −9 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −8 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −7 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −6 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −5 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| −4 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −3 | K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −2 | K090461 | Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0 | Tomtec Imaging Systems GmbH | 2009 | 1 |
| −1 | K103782 | 4D MV-Assessment 2.0 | Tomtec Imaging Systems GmbH | 2011 | — |
| 0 (this device) | 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 |
| +1 | K200232 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2020 | — |
| +4 | K181685 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 8 | 0 |
| 1996 | 5 | 0 |
| 1997 | 8 | 0 |
| 1998 | 3 | 0 |
| 1999 | 10 | 0 |
| 2000 | 7 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 11 | 0 |
| 2005 | 4 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (8)
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 1…iving and communications system Programmable diagnostic computer Proprietary Name: TomTec-Arena 1.0 Predicate Devices Predicate Device 1 K071232 Image-Arena Applications, Research- Arena Applications: 4D RV-Function 1.0,… | 2007 |
| * | K090461 | Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Summary page 1…h- Arena Applications: 4D RV-Function 1.0, 4D Cardio-View 2.0, 4D LV-Function 2.0 Predicate Device 2 K090461 Image-Arena 4.0 and Image-Arena Applications: 2D Cardiac Performance… | 2009 |
| * | K103782 | 4D MV-Assessment 2.0Summary page 1…Image-Arena 4.0 and Image-Arena Applications: 2D Cardiac Performance Analysis 1.0 Predicate Device 3 K103782 40 MV-Assessment 2.0 Predicate Device 4 K1 10595 40 Sono-Scan 1.0 Predicate DeviceS5 K1 10667 Image-Arena and I… | 2011 |
| * | K110595 | 4D Sono-Scan 1.0Summary page 1…Applications: 2D Cardiac Performance Analysis 1.0 Predicate Device 3 K103782 40 MV-Assessment 2.0 Predicate Device 4 K1 10595 40 Sono-Scan 1.0 Predicate DeviceS5 K1 10667 Image-Arena and Image-Arena Application… | 2011 |
| * | K110667 | Image-Arena and Image-Arena ApplicationsSummary page 1…Analysis 1.0 Predicate Device 3 K103782 40 MV-Assessment 2.0 Predicate Device 4 K1 10595 40 Sono-Scan 1.0 Predicate DeviceS5 K1 10667 Image-Arena and Image-Arena Applications Image-Arena 4.5, Echo-Coin… | 2011 |
| * | K110746 | 4D LV-Analysis 3.0Summary page 1…Arena and Image-Arena Applications Image-Arena 4.5, Echo-Coin 4.5, Image-Coin 4.5 Predicate Device 6 K1 10746 40 LV-Analysis 3.0 Predicate Device 7 K120135 20 Cardiac Performance Analysis MR 1.0 Predicate DeviceS8 K122289… | 2011 |
| * | K120135 | 2D Cardiac Performance Analysis MR 1.0Summary page 1…Applications Image-Arena 4.5, Echo-Coin 4.5, Image-Coin 4.5 Predicate Device 6 K1 10746 40 LV-Analysis 3.0 Predicate Device 7 K120135 20 Cardiac Performance Analysis MR 1.0 Predicate DeviceS8 K122289 Image-Coin 5.0 summary… | 2012 |
| * | K122289 | Image-Com 5.0Summary page 1…4.5, Image-Coin 4.5 Predicate Device 6 K1 10746 40 LV-Analysis 3.0 Predicate Device 7 K120135 20 Cardiac Performance Analysis MR 1.0 Predicate DeviceS8 K122289 Image-Coin 5.0 summary ;1page 1 of 4… | 2012 |
What descends from it? (78)
See all 783 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 18 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 19 of the 110 ancestors have a recall of any class.
- Of its descendants, K150122 (Tomtec Imaging Systems GmbH, 2015) has gone furthest, with 56 descendants of its own.
- 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. 2013, 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?
Indications for use of Tom-fec-Arena software are diagnostic review, quantification and reporting of cardiovascular, fetal and abdominal structures and function of patients with suspected disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132544: Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-Arena.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132544
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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