510(k) · Cleared
ClearedTribusConnect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tribusmed Beheer BV · QIH Automated Radiological Image Processing Software
Cleared on Mar 31, 2025 as substantially equivalent to K141061 (Neologica S.R.L., 2014) and 1 other predicate after a 250-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Mar 31, 2025
- Review
- 250 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K954678 (1996). 27 ancestors in all, the oldest K896095 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations between
- 3 generations backK153736 3mensio WorkstationPie Medical Imaging BV · 2016 · Recalled
- 2 generations backK202212 TruPlanCircle Cardiovascular Imaging, Inc. · 2021
- 1 generation backK222593 TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc. · 2023
- This deviceK242166 TribusConnectTribusmed Beheer BV · 2025
Show all 9 generations
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 8 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 7 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 6 generations backK043097 3VISEON3Mensio Medical Imaging BV · 2004
- 5 generations backK072653 3VISEON/Surgery3Mensio Medical Imaging BV · 2008
- 4 generations backK120367 3MENSIO WorkstationPie Medical Imaging BV · 2012
- 3 generations backK153736 3mensio WorkstationPie Medical Imaging BV · 2016 · Recalled
- 2 generations backK202212 TruPlanCircle Cardiovascular Imaging, Inc. · 2021
- 1 generation backK222593 TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc. · 2023
- This deviceK242166 TribusConnectTribusmed Beheer BV · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −8 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −7 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −6 | K043097 | 3VISEON | 3Mensio Medical Imaging BV | 2004 | — |
| −5 | K072653 | 3VISEON/Surgery | 3Mensio Medical Imaging BV | 2008 | — |
| −4 | K120367 | 3MENSIO Workstation | Pie Medical Imaging BV | 2012 | — |
| −3 | K153736 | 3mensio Workstation | Pie Medical Imaging BV | 2016 | 1 |
| −2 | K202212 | TruPlan | Circle Cardiovascular Imaging, Inc. | 2021 | — |
| −1 | K222593 | TruPlan Computed Tomography (CT) Imaging Software | Circle Cardiovascular Imaging, Inc. | 2023 | — |
| 0 (this device) | K242166 | TribusConnect | Tribusmed Beheer BV | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 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? (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 |
|---|---|---|---|
| * | K141061 | Remoteye ViewerSummary page 5…umber: 21 CFR 892.2050 Product Code(s): QIH, LLZ Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K141061 RemotEye Viewer LLZ K222593 TruPlan Computed Tomography (CT) Imaging Softw… | 2014 |
| * | K222593 | TruPlan Computed Tomography (CT) Imaging SoftwareSummary page 5…Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K141061 RemotEye Viewer LLZ K222593 TruPlan Computed Tomography (CT) Imaging Software QIH Device Description Summary TribusConnect consists of the following… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- 6 of the 27 ancestors have a recall of any class.
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. 2025, 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?
TribusConnect is a medical image management and processing device which facilitates remote viewing on different locations of CT images stored in DICOM format, allowing healthcare professionals to access, review, manipulate, measure and visualize simulated patient data from different sources. TribusConnect is suitable for, but not limited to, pre-procedural planning of cardiac interventions and post procedural analysis of cardiac interventions. To…
Read the full statement (150 words)
TribusConnect is a medical image management and processing device which facilitates remote
viewing on different locations of CT images stored in DICOM format, allowing healthcare
professionals to access, review, manipulate, measure and visualize simulated patient data from
different sources.
TribusConnect is suitable for, but not limited to, pre-procedural planning of cardiac interventions and
post procedural analysis of cardiac interventions.
To facilitate the above, TribusConnect uses CT DICOM data to output volume renderings, ML-based
heart segmentation, a simulated fluoroscopy view, endo views, MIP and MPR views.
Measurements can only be performed on MPR views.
TribusConnect is not intended for diagnostic use on mobile displays.
TribusConnect is not intended to serve as the primary archive for medical imaging data.
TribusConnect is an adjunct tool and is not intended to replace a physician’s own review on the
images.
The intended patient population is comprised of adult patients (22 years of age and older)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242166: TribusConnect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242166
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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