# K110834: AW Volumeshare 5 with Angioviz Option

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Apr 26, 2011 after 32 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K913770 (1991). 11 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052995: Advantage Workstation 4.3., GE Healthcare (2005) Summary page 1.

## Most influential descendants
- K142736: XIDF-AWS801, Angio Workstation, v5.31 (2015), 6 descendants of its own
- K150967: XIDF-AWS801, Angio Workstation, V6.10 (2015), 5 descendants of its own
- K152785: XIDF-AWS801, Angio Workstation, V6.20 (2015), 4 descendants of its own
- K172646: XIDF-AWS801, Angio Workstation, V7.0 (2017), 3 descendants of its own
- K181415: XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 (2018), 2 descendants of its own

## Recalls of this device
- Sep 19, 2013 · Class II · Z-0270-2014: GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Se

## Indications for use
AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may, be used as a basis of diagnosis, except in the case of mammography images. AngioViz is an application which produces from a OSA series parametric images representing maximum opacification, time to peak and combinations of those, to enable the user to more easily visualize characteristics related to vascular flow. The AngioViz application can be used to process USA image data from any location in the human body for which USA imaging is used.

Source page: https://510kreport.com/device/K110834
Methodology: https://510kreport.com/methodology