510(k) · Cleared
ClearedTomtec-Arena
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tomtec Imaging Systems GmbH · QIH Automated Radiological Image Processing Software
Cleared on Jan 6, 2022 as substantially equivalent to K201632 (Tomtec Imaging Systems GmbH, 2020) after a 59-day review. Its family tree reaches back 19 generations to 1995. 6 later devices descend from it.
- Decided
- Jan 6, 2022
- Review
- 59 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K935595 (1995). 146 ancestors in all, the oldest K891449 (1989). 6 later devices descend from it, 3 citing it directly.
- Root · 19 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 15 generations between
- 3 generations backK191647 QLAB Advanced Quantification SoftwarePhilips Health Care · 2019
- 2 generations backK200974 QLAB Advanced Quantification SoftwarePhilips Health Care · 2020
- 1 generation backK201632 Tomtec-ArenaTomtec Imaging Systems GmbH · 2020
- This deviceK213544 Tomtec-ArenaTomtec Imaging Systems GmbH · 2022
- Descendant · cites it directly · 3 of its ownK230209 Sonix HealthOntact Health Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK243684 BrightHeart View ClassifierBrightheart · 2025
- Descendant · cites it directly · 0 of its ownK250330 3mensio WorkstationPie Medical Imaging BV · 2025 · Recalled
- Descendant · 3 generations on · 0 of its ownK251456 BrightHeart View ClassifierBrightheart · 2025
- Descendant · cites it directly · 0 of its ownK241659 Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC · 2025
Show all 19 generations
- Root · 19 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 18 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 17 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 16 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 15 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 14 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 13 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 12 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 11 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 10 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 9 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 8 generations backK091286 Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009
- 7 generations backK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
- 6 generations backK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · Recalled
- 5 generations backK171314 QLAB Advanced Quantification SoftwarePhilips Health Care · 2017
- 4 generations backK181264 QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc. · 2018
- 3 generations backK191647 QLAB Advanced Quantification SoftwarePhilips Health Care · 2019
- 2 generations backK200974 QLAB Advanced Quantification SoftwarePhilips Health Care · 2020
- 1 generation backK201632 Tomtec-ArenaTomtec Imaging Systems GmbH · 2020
- This deviceK213544 Tomtec-ArenaTomtec Imaging Systems GmbH · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K230209Sonix HealthOntact Health Co., Ltd. · 2023 · cites it directly3descendants
- K243684BrightHeart View ClassifierBrightheart · 2025 · 2 generations on1descendant
- K2503303mensio WorkstationPie Medical Imaging BV · 2025 · cites it directly0descendants
- K251456BrightHeart View ClassifierBrightheart · 2025 · 3 generations on0descendants
- K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −18 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −17 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −16 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −15 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −14 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −13 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −12 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −11 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| −10 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −9 | K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −8 | K091286 | Syngo US Workplace | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −7 | K130159 | Qlab Quantification Software Heart Model | Philips Health Care | 2013 | — |
| −6 | K132165 | Qlab Quantification Software | Philips Ultrasound, Inc. | 2013 | 1 |
| −5 | K171314 | QLAB Advanced Quantification Software | Philips Health Care | 2017 | — |
| −4 | K181264 | QLAB Advanced Quantification Software | Philips Ultrasound, Inc. | 2018 | — |
| −3 | K191647 | QLAB Advanced Quantification Software | Philips Health Care | 2019 | — |
| −2 | K200974 | QLAB Advanced Quantification Software | Philips Health Care | 2020 | — |
| −1 | K201632 | Tomtec-Arena | Tomtec Imaging Systems GmbH | 2020 | — |
| 0 (this device) | K213544 | Tomtec-Arena | Tomtec Imaging Systems GmbH | 2022 | — |
| +1 | K230209 | Sonix Health | Ontact Health Co., Ltd. | 2023 | — |
| +2 | K243684 | BrightHeart View Classifier | Brightheart | 2025 | — |
| +1 | K250330 | 3mensio Workstation | Pie Medical Imaging BV | 2025 | 1 |
| +3 | K251456 | BrightHeart View Classifier | Brightheart | 2025 | — |
| +1 | K241659 | Ultrasound Workspace (UWS 6.0) | Philips Ultrasound, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 6 | 0 |
| 1997 | 9 | 0 |
| 1998 | 5 | 0 |
| 1999 | 11 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 9 | 0 |
| 2003 | 5 | 0 |
| 2004 | 14 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K201632 | Tomtec-ArenaSummary page 6…. The semi-automated measurements are licensed separately. 5) SUBSTANTIALLY EQUIVALENT DEVICES Predicate Device: TOMTEC-ARENA K201632 (August 14, 2020) Reference Device: EPIQ and Affiniti Series Diagnostic Ultrasound System… | 2020 |
| † | K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | 2021 |
What descends from it? (6)
3 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 27 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 30 of the 146 ancestors have a recall of any class.
- Of its descendants, K230209 (Ontact Health Co., Ltd., 2023) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K201632.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis.
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/K213544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213544: Tomtec-Arena.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213544
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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