# K071362: Vital Connect 4.1

- Pathway: 510(k) (Abbreviated)
- Applicant: Vital Images, Inc.
- Decided: May 30, 2007 after 15 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K913770 (1991). 37 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062154: Vital Connect 4.0, Vital Images, Inc. (2006) Summary page 1.
- K061624: Vitrea, Version 3.9, Vital Images, Inc. (2006) Summary page 1.

## Most influential descendants
- 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
- K230249: Ikshana (2023), 1 descendant 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
- 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 4.1. 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. ViTALConnect is not meant for primary image interpretation in mammography. Inaddition, the ViTALConnect system has the following specific intended use: Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross sectional measurements can be obtained using standard Vital Images software measuring tools. Clinicians can manually measure the lumen width to obtain percentage stenosis calculations, based on the ratio of the smallest to the largest diameter. In addition, clinicians can manually measure vessel length along the centerline in standard curved MPR views and examine Hounsfield Units statistics. CT Coronary Artery Analysis is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians can select any coronary artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at 90 degree angles to each other, and cross sections of the vessel. The clinician can semi-automatically determine contrasted lumen boundaries, stenosis measurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Houndsfield unit statistics.

Source page: https://510kreport.com/device/K071362
Methodology: https://510kreport.com/methodology