# K242166: TribusConnect

- Pathway: 510(k) (Traditional)
- Applicant: Tribusmed Beheer BV
- Decided: Mar 31, 2025 after 250 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K954678 (1996). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141061: Remoteye Viewer, Neologica S.R.L. (2014) Summary page 5.
- K222593: TruPlan Computed Tomography (CT) Imaging Software, Circle Cardiovascular Imaging, Inc. (2023) Summary page 5.

## Indications for use
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)

Source page: https://510kreport.com/device/K242166
Methodology: https://510kreport.com/methodology