# K062154: Vital Connect 4.0

- Pathway: 510(k) (Abbreviated)
- Applicant: Vital Images, Inc.
- Decided: Aug 10, 2006 after 13 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K913770 (1991). 20 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040876: Iconnection, Version 3.2.0.0 Medical Image Processing Software, Vital Images, Inc. (2004) Summary page 1.

## Most influential descendants
- K071362: Vital Connect 4.1 (2007), 11 descendants of its own
- K150738: VitreaView (2015), 8 descendants of its own
- K163232: Vitrea View (2017), 7 descendants of its own
- K190764: SurgicalAR (2019), 6 descendants of its own
- K213215: VSI HoloMedicine (2022), 2 descendants of its own

## Recalls of this device
- Oct 21, 2013 · Class II · Z-0169-2014: Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a potential for incorrect and possibly reversed image orientation for certain snapshots taken in VitreaCo
- Feb 5, 2013 · Class II · Z-1002-2013: Vital Images has found a potential error in measurement generated through the software which affects all versions of Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitr
- Aug 23, 2010 · Not classified · Z-1021-2011: There is a potential alignment error of fused PET/CT images in the Vitrea Core component of Vitrea Enterprise Suite 1.2 and 1.3. The error occurs during panning of the fused PET/CT images. Because the
- Nov 8, 2007 · Not classified · Z-0520-2008: Standard Uptake Values (SUV) display/update problems; in the way Standard Uptake Values (SUV) are displayed in 3D/MPR views. The problem arises when a user draws a selected region of interest in order

## Indications for use
ViTALConnect, Version 4.0 is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a vanety of imaging devices including: CT, MR, CR/DRIDX, SC, US, NM, PET, -XA, and RF, etc. In addition, the ViTALConnect system has the following specific intended uses: Advanced Vessel Analysis is an option within the ViTALConnect 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 ViTALConnect 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 ViTALConnect system that allows multiple users to collaboratively interact with ViTALConnect system features and tools.

Source page: https://510kreport.com/device/K062154
Methodology: https://510kreport.com/methodology