# K040876: Iconnection, Version 3.2.0.0 Medical Image Processing Software

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Apr 19, 2004 after 14 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 5 generations back to K913770 (1991). 19 ancestors in all.
30 later devices descend from it; 3 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032748: VITREA2, Version 3.4 Medical Image Processing Software, Vital Images, Inc. (2003) Summary page 1.
- K012779: Iconnection 3D, Hinnovation, Inc. (2001) Summary page 1.

## Most influential descendants
- K110256: The IC-Pro System (2011), 15 descendants of its own
- K062154: Vital Connect 4.0 (2006), 12 descendants of its own
- K071362: Vital Connect 4.1 (2007), 11 descendants of its own
- K133993: Caas Workstation (2014), 10 descendants of its own
- K151780: CAAS Workstation (2016), 9 descendants of its own

## Indications for use
iConnection 3D1 is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. In addition, the iConnection system has the following specific intended uses: Advanced Vessel Analysis is an option within the iConnection system intended to aid clinicians in the study and analysis of selected vessels, the inspection of circulatory anatomy, the quantification of stenosis, distance measurements and cross-sectional diameters, volume measurements, and assist in the planning and monitoring of vascular therapies. The feature operates with CT and MRI data. Pet Visualization is an option within the iConnection system that provides for the overlay, inspection, and measurement of two different image modalities (primarily directed at PET/CT). The option also includes the ability to measure Standard Uptake Values on PET datasets. The overlay operation enables clinicians to obtain a better understanding of the joint information that would otherwise have to be compared separately. It is important to note that the clinician retains the ultimate responsibility for making pertinent diagnosis based on their standard procedures, including visual comparison of separate images. Collaboration Mode is a capability within the iConnection system that allows multiple users to collaboratively interact with iConnection system features and tools.

Source page: https://510kreport.com/device/K040876
Methodology: https://510kreport.com/methodology